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FDA Drug NDCs / Labels

86

Labels
NDA Filings Bosutinib monohydrate , palbociclib , glasdegib , Meropenem , nifedipine , azithromycin dihydrate , prazosin hydrochloride , tafamidis , nitroglycerin , PREGABALIN , gabapentin , TAZOBACTAM SODIUM and PIPERACILLIN SODIUM , levothyroxine sodium , ramipril , spironolactone and hydrochlorothiazide , Celecoxib , disopyramide phosphate , conjugated estrogens , conjugated estrogens and medroxyprogesterone acetate , axitinib , amlodipine besylate , amlodipine besylate and atorvastatin calcium , Doxorubicin Hydrochloride , piroxicam , SIROLIMUS , temsirolimus , liothyronine sodium , quinupristin and dalfopristin , estrogens, conjugated , Heparin Sodium , Dalteparin Sodium , lorlatinib , Sunitinib malate , doxycycline calcium , tofacitinib , dacomitinib , sildenafil citrate , dofetilide , quinapril hydrochloride and hydrochlorothiazide , VENLAFAXINE HYDROCHLORIDE , ethionamide , penicillin G benzathine and penicillin G procaine , silver sulfadiazine , nafarelin acetate , spironolactone , diclofenac sodium and misoprostol , metronidazole , benzonatate , atorvastatin calcium , quinapril hydrochloride , crisaborole , metaxalone , eplerenone , CRIZOTINIB , Phenelzine Sulfate , methsuximide , gemfibrozil , penicillin G benzathine , trimethobenzamide hydrochloride , verapamil hydrochloride , varenicline tartrate , talazoparib , tafamidis meglumine , hydroxyzine pamoate , Fosphenytoin Sodium , desvenlafaxine succinate , PANTOPRAZOLE SODIUM , doxycycline , Ethosuximide , oxaprozin , fesoterodine fumarate , conjugated estrogens/bazedoxifene , TIGECYCLINE , diphenoxylate hydrochloride and atropine sulfate , misoprostol , doxycycline hyclate , Phenytoin , Diclofenac Epolamine , neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone , echothiophate iodide , neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate , TOFACITINIB CITRATE

Authorized Generic Drugs romidepsin

ANDAs (Approved New Drug Applications) methimazole , esterified estrogens , penicillin g procaine , Phenytoin , Ethosuximide , Propofol , Extended Phenytoin Sodium , AMPICILLIN SODIUM; SULBACTAM SODIUM

Unapproved Drugs azithromycin dihydrate

BLA trastuzumab , Taliglucerase alfa , rituximab-pvvr , filgrastim-aafi , epoetin alfa-epbx , bevacizumab-bvzr , Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine) , gemtuzumab ozogamicin , infliximab-dyyb , inotuzumab ozogamicin

private labels NovaPlus Premier Intalere Northstar Civica BluePoint Schien (HF or GI)
Vertically Integrated (estimated) doxorub, heparin, neomyci, hydroxy,

FDA Approved Drug Filings

98

Active approvals
Active Approvals / Active Suppliers: PFIZER , PFIZER INC , PFIZER PHARMS

FDA Drugs Approvals Returned: DISOPYRAMIDE PHOSPHATE , NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE , PIROXICAM , METRONIDAZOLE , PAROMOMYCIN SULFATE , PALBOCICLIB , GEMFIBROZIL , PREGABALIN , PRAZOSIN HYDROCHLORIDE , POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE , THIOTHIXENE , AMPICILLIN/AMPICILLIN TRIHYDRATE , NIFEDIPINE , DOXEPIN HYDROCHLORIDE , ZALEPLON , TALAZOPARIB TOSYLATE , TROLEANDOMYCIN , OXYTETRACYCLINE HYDROCHLORIDE , BENZONATATE , DOFETILIDE , DOXYLAMINE SUCCINATE , OXAMNIQUINE , DOXYCYCLINE HYCLATE , HYDROXYZINE PAMOATE , AZITHROMYCIN , THIOTHIXENE HYDROCHLORIDE , TIOCONAZOLE , PENICILLIN G POTASSIUM , PENICILLIN V POTASSIUM , AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE , FLUCONAZOLE , BACAMPICILLIN HYDROCHLORIDE , DOXYCYCLINE , BACITRACIN , IRINOTECAN HYDROCHLORIDE , ALPROSTADIL , CEFOPERAZONE SODIUM , HYDROCORTISONE ACETATE , DOCETAXEL , EPIRUBICIN HYDROCHLORIDE , BENZQUINAMIDE HYDROCHLORIDE , METRONIDAZOLE HYDROCHLORIDE , DALTEPARIN SODIUM , HEPARIN SODIUM , MEROPENEM , PLICAMYCIN , PENICILLIN G PROCAINE , PREDNISOLONE ACETATE , STREPTOMYCIN SULFATE , LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE , PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE , TETRACYCLINE HYDROCHLORIDE , SPECTINOMYCIN HYDROCHLORIDE , ALATROFLOXACIN MESYLATE , AMPICILLIN SODIUM; SULBACTAM SODIUM , VIOMYCIN SULFATE , HYDROXYZINE HYDROCHLORIDE , OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE , HYDROCORTISONE , HYDROCORTAMATE HYDROCHLORIDE , TOFACITINIB CITRATE , NICOTINE , NAFARELIN ACETATE , HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE , ZIPRASIDONE HYDROCHLORIDE , DOXYCYCLINE CALCIUM , OXYTETRACYCLINE CALCIUM , DICLOFENAC SODIUM; MISOPROSTOL , VERAPAMIL HYDROCHLORIDE , GLIPIZIDE , FESOTERODINE FUMARATE , QUINAPRIL HYDROCHLORIDE , HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE , HYDROCHLOROTHIAZIDE; SPIRONOLACTONE , SPIRONOLACTONE , RAMIPRIL , MISOPROSTOL , OXYPHENCYCLIMINE HYDROCHLORIDE , GLASDEGIB MALEATE , OXAPROZIN , OXAPROZIN POTASSIUM , CHLORPROPAMIDE , BENZTHIAZIDE , CARBENICILLIN INDANYL SODIUM , LITHIUM CARBONATE , ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE , LORLATINIB , RESCINNAMINE , NEOMYCIN SULFATE , ERYTHROMYCIN STEARATE , POLYTHIAZIDE , POLYTHIAZIDE; RESERPINE , TROGLITAZONE , PREDNISOLONE , OXYTETRACYCLINE , TROVAFLOXACIN MESYLATE , DACOMITINIB , ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE

Active Pharmaceutical Ingredients

2

Active API Holders
Companies with Active APIs PFIZER INC , PHARMACIA AN

APIs Returned HYDROCORTISONE MICRONIZED AND , PROGESTERONE MICRONIZED AND CR , MEGESTROL ACETATE USP , DOXORUBICIN HYDROCHLORIDE , GLIPIZIDE USP , HEPARIN SODIUM USP , TESTOSTERONE, USP , TESTOSTERONE PROPIONATE , TESTOSTERONE CYPIONATE USP , DEXAMETHASONE USP MICRONIZED , DEXAMETHASONE ACETATE USP ANHY , METHYLPREDNISOLONE USP KALAMAZ , METHYLPREDNISOLONE ACETATE USP , MEDROXYPROGESTERONE ACETATE US , ESTRADIOL CYPIONATE USP , DINOPROSTONE USP , DINOPROST TROMETHAMINE , HYDROCORTISONE ACETATE USP, MI , EPOPROSTENOL SODIUM (U-53,217A , ESTRAMUSTINE PHOSPHATE SODIUM , DEXAMETHASONE SODIUM PHOSPHATE , 16A-HYDROXYPREDNISOLONE , BETAMETHYL EPOXIDE , ALPHAMETHYL EPOXIDE , LINCOMYCIN HYDROCHLORIDE USP , NOVOBIOCIN SODIUM , NEOMYCIN SULFATE USP , CLINDAMYCIN PHOSPHATE USP, KAL , TESTOSTERONE UNDECANOATE , PRASTERONE ACETATE , CABERGOLINE USP , ACTIVATED CALICHEAMICIN DERIVA , PROGESTERONE USP , HYDROXYPROGESTERONE CAPROATE U

Tentative FDA Drug Approvals

1

Tentative Approvals
PFIZER INC - ZOLEDRONIC ACID - 4MG/5ML - INJECTABLE;INJECTION

Pharma Drug Patents

44

Patents
PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for U-449: USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER SQUARE METER with EXPIRY of 2020-04-28

PFIZER patent for VIZIMPRO ( DACOMITINIB) for U-1403: FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST with EXPIRY of 2025-05-05

KING PFIZER patent for ALTACE ( RAMIPRIL) for U-871: METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH with EXPIRY of 2020-08-30

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for U-913: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY with EXPIRY of 2027-06-07

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for U-913: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY with EXPIRY of 2022-07-03

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for U-247: TREATMENT OF RHEUMATOID ARTHRITIS with EXPIRY of 2020-12-08

PFIZER patent for TROXYCA ER ( NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE) for U-1508: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED with EXPIRY of 2025-07-03

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for U-2437: TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER with EXPIRY of 2029-07-27

PFIZER patent for IBRANCE ( PALBOCICLIB) for U-1998: TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY with EXPIRY of 2023-01-16

PFIZER patent for IBRANCE ( PALBOCICLIB) for U-2515: PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY with EXPIRY of 2023-01-16

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2137: TREATMENT OF POSTHERPETIC NEURALGIA with EXPIRY of 2026-11-02

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2136: TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY with EXPIRY of 2026-11-02

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2137: TREATMENT OF POSTHERPETIC NEURALGIA with EXPIRY of 2026-11-02

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2136: TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY with EXPIRY of 2026-11-02

PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for U-606: USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER with EXPIRY of 2020-05-01

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for U-913: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY with EXPIRY of 2027-06-07

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for U-2322: TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC) with EXPIRY of 2020-12-08

PFIZER patent for LORBRENA ( LORLATINIB) for U-2633: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER, PROGRESSED ON: CRIZOTINIB + AT LEAST 1 OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB, OR CERITINIB AS FIRST ALK INHIBITOR FOR METASTATIC DISEASE. with EXPIRY of 2036-07-27

PFIZER patent for DAURISMO ( GLASDEGIB MALEATE) for : with EXPIRY of 2028-06-29

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2020-12-08

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2023-03-25

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2026-11-02

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2023-01-16

PFIZER patent for TROXYCA ER ( NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE) for : with EXPIRY of 2027-12-12

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2029-10-19

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2023-01-16

PFIZER patent for VIZIMPRO ( DACOMITINIB) for : with EXPIRY of 2028-08-26

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2034-02-08

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2020-12-08

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for : with EXPIRY of 2027-06-07

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2031-10-20

PFIZER patent for LORBRENA ( LORLATINIB) for : with EXPIRY of 2033-03-05

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2031-10-20

PFIZER INC patent for GEODON ( ZIPRASIDONE HYDROCHLORIDE) for : with EXPIRY of 2020-05-18

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2020-12-08

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2029-07-27

PFIZER patent for DAURISMO ( GLASDEGIB MALEATE) for : with EXPIRY of 2036-04-13

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2034-03-14

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2023-01-16

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2025-12-08

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2034-03-14

PFIZER patent for DAURISMO ( GLASDEGIB MALEATE) for : with EXPIRY of 2031-01-30

PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for : with EXPIRY of 2020-10-28

PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for : with EXPIRY of 2020-11-01

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2027-05-02

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2027-05-02

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2027-05-02


FDA Drug Exclusivity

92

Exclusivities
PFIZER PALBOCICLIB - IBRANCE - 75MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 125MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 100MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 125MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 75MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 100MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PREGABALIN - LYRICA - 300MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 225MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 200MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 150MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 100MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 75MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 50MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 25MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 20MG/ML - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA CR - 82.5MG - NP:NEW PRODUCT -2020-10-11
PFIZER PREGABALIN - LYRICA CR - 165MG - NP:NEW PRODUCT -2020-10-11
PFIZER PREGABALIN - LYRICA CR - 330MG - NP:NEW PRODUCT -2020-10-11
PFIZER TOFACITINIB CITRATE - XELJANZ XR - EQ 11MG BASE - I-761:NEW INDICATION (SEE INDIVIDUAL REFERENCES) -2020-12-14
PFIZER PREGABALIN - LYRICA CR - 330MG - PED:PEDIATRIC EXCLUSIVITY -2021-04-11
PFIZER PREGABALIN - LYRICA CR - 165MG - PED:PEDIATRIC EXCLUSIVITY -2021-04-11
PFIZER PREGABALIN - LYRICA CR - 82.5MG - PED:PEDIATRIC EXCLUSIVITY -2021-04-11
PFIZER PREGABALIN - LYRICA - 300MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 225MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 200MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 150MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 100MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 75MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 50MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 25MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 20MG/ML - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 300MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 225MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 200MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 150MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 100MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 75MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 50MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 25MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 20MG/ML - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER DALTEPARIN SODIUM - FRAGMIN - 18,000IU/0.72ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 15,000IU/0.6ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 12,500IU/0.5ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 7,500 IU/0.75ML - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 95,000IU/9.5ML (10,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 95,000IU/3.8ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 7,500IU/0.3ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 10,000IU/ML (10,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 5,000IU/0.2ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 10,000IU/0.4ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 2,500IU/0.2ML (12,500IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER PREGABALIN - LYRICA - 300MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 225MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 200MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 150MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 100MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 75MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 50MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 25MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 20MG/ML - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 300MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 225MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 200MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 150MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 100MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 75MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 50MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 25MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 20MG/ML - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER DACOMITINIB - VIZIMPRO - 45MG - NCE:NEW CHEMICAL ENTITY -2023-09-27
PFIZER DACOMITINIB - VIZIMPRO - 15MG - NCE:NEW CHEMICAL ENTITY -2023-09-27
PFIZER DACOMITINIB - VIZIMPRO - 30MG - NCE:NEW CHEMICAL ENTITY -2023-09-27
PFIZER TALAZOPARIB TOSYLATE - TALZENNA - EQ 0.25MG BASE - NCE:NEW CHEMICAL ENTITY -2023-10-16
PFIZER TALAZOPARIB TOSYLATE - TALZENNA - EQ 1MG BASE - NCE:NEW CHEMICAL ENTITY -2023-10-16
PFIZER LORLATINIB - LORBRENA - 25MG - NCE:NEW CHEMICAL ENTITY -2023-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - NCE:NEW CHEMICAL ENTITY -2023-11-02
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 100MG BASE - NCE:NEW CHEMICAL ENTITY -2023-11-21
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 25MG BASE - NCE:NEW CHEMICAL ENTITY -2023-11-21
PFIZER DACOMITINIB - VIZIMPRO - 45MG - ODE-206:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 45MG - ODE-213:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 15MG - ODE-206:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 15MG - ODE-213:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 30MG - ODE-206:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 30MG - ODE-213:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER LORLATINIB - LORBRENA - 25MG - ODE-218:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 25MG - ODE-217:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 25MG - ODE-219:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - ODE-218:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - ODE-219:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - ODE-217:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 100MG BASE - ODE-224:ORPHAN DRUG EXCLUSIVITY -2025-11-21
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 25MG BASE - ODE-224:ORPHAN DRUG EXCLUSIVITY -2025-11-21

Federal Supply Schedule Pricing

2

Vendors on FSS
Companies on Federal Supply Schedule Pfizer, Inc. , Pfizer Inc.

Pharmaceutical Drugs on Federal Supply Schedule PANTOPRAZOLE NA 40MG/VIL INJ , SIROLIMUS 1MG/ML SOLN,ORAL , SIROLIMUS 0.5MG TAB , NEISSERIA MENINGITIDIS VACCINE (TRUMENBA) INJ,0.5ML,SYR , PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE , PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE/0.5ML , INOTUZUMAB OZOGAMICIN 0.9MG/VIL INJ , ANTIVENIN,MICRURUS FULVIUS INJ , PANTOPRAZOLE NA 40MG TAB,EC , PANTOPRAZOLE NA 20MG TAB,EC , PANTOPRAZOLE NA 40MG/PKT PWDR,ORAL , SIROLIMUS 0.5MG PK 10X10, TAB , SIROLIMUS 1MG TAB , SIROLIMUS 1MG TAB,UD , SIROLIMUS 2MG TAB , BAZEDOXIFENE 20MG/ESTROGENS,CONJUGATED 0.45MG TAB , TEMSIROLIMUS 25MG/ML INJ,VIAL , DESVENLAFAXINE (EQV-PRISTIQ) 25MG TAB,SA , DESVENLAFAXINE 50MG TAB,SA, , DESVENLAFAXINE 50MG TAB,SA , DESVENLAFAXINE 100MG TAB,SA , ETHIONAMIDE 250MG TAB , GEMTUZUMAB OZOGAMICIN 5MG/VIL INJ , TIGECYCLINE 50MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 500MG/VIL INJ , HYDROCORTISONE NA SUCCINATE 1000MG/VIL INJ,SOLN , HYDROCORTISONE NA SUCCINATE 100MG/VIL INJ,SOLN , HYDROCORTISONE NA SUCCINATE 50MG/ML INJ,SOLN , HYDROCORTISONE 5MG TAB , HYDROCORTISONE NA SUCCINATE 125MG/ML INJ,SOLN , HYDROCORTISONE NA SUCCINATE 500MG/VIL INJ,SOLN , TRIAZOLAM 0.25MG TAB , METHYLPREDNISOLONE NA SUCCINATE 1000MG/VIL INJ , METHYLPREDNISOLONE 2MG TAB , METHYLPREDNISOLONE 8MG TAB , HYDROCORTISONE 10MG TAB , METHYLPREDNISOLONE NA SUCCINATE 40MG/VIL INJ , HYDROCORTISONE 20MG TAB , METHYLPREDNISOLONE NA SUCCINATE 125MG/VIL INJ , MEDROXYPROGESTERONE ACETATE 10MG TAB , METHYLPREDNISOLONE 4MG TAB , METHYLPREDNISOLONE 4MG TAB DOSEPAK,21 , MEDROXYPROGESTERONE ACETATE 2.5MG TAB , METHYLPREDNISOLONE 16MG TAB , METHYLPREDNISOLONE 32MG TAB , CLINDAMYCIN HCL 150MG CAP , BACITRACIN 50000UNT/VIL INJ , COLESTIPOL HCL 5GM/PKT GRANULES , COLESTIPOL GRANULES , ESTRADIOL CYPIONATE 5MG/ML INJ (IN OIL) , METHYLPREDNISOLONE ACETATE 20MG/ML INJ,SUSP , METHYLPREDNISOLONE ACETATE 40MG/ML INJ,SUSP , MEDROXYPROGESTERONE ACETATE 5MG TAB , METHYLPREDNISOLONE ACETATE 80MG/ML INJ,SUSP , GELATIN,ABSORBABLE SPONGE,SZ 12,7MM , GELATIN,ABSORBABLE SPONGE,SZ 50 , CLINDAMYCIN HCL 75MG CAP , GLYBURIDE 1.5MG TAB , GELATIN,ABSORBABLE SPONGE,SZ 100 , TESTOSTERONE CYPIONATE 100MG/ML INJ (IN OIL) , GELATIN,ABSORBABLE SPONGE,SZ 200 , GLYBURIDE 3MG TAB , COLESTIPOL HCL 7.5GM/PKT GRANULES,FLAVORED , COLESTIPOL HCL GRANULES,FLAVORED , CLINDAMYCIN HCL 300MG CAP , GELATIN,ABSORBABLE SPONGE,DENTAL SIZE 4 , TESTOSTERONE CYPIONATE 200MG/ML INJ (IN OIL) , GELATIN,ABSORBABLE PWDR , ARGININE HCL 30GM/300ML INJ , COLESTIPOL HCL 1GM TAB , LINCOMYCIN HCL 300MG/ML INJ , MEDROXYPROGESTERONE ACETATE 400MG/ML INJ,SUSP , CLINDAMYCIN PO4 150MG/ML INJ , MEDROXYPROGESTERONE ACETATE 150MG/ML INJ,SUSP , DINOPROSTONE 20MG SUPP,VAG , METHYLPREDNISOLONE NA SUCCINATE 2000MG/VIL INJ , CARBOPROST 250MCG/TROMETHAMINE 83MCG/ML INJ , CLINDAMYCIN PO4 150MG/ML INJ,VIL,2ML , THROMBIN 5,000UNIT/VIL (BOVINE) SPRAY,TOP KIT , ALPROSTADIL 500MCG/ML INJ , CLINDAMYCIN PO4 1% LOTION , CLINDAMYCIN PO4 1% GEL,TOP , DINOPROSTONE 0.5MG/3GM APPLICATOR,VAG , CLINDAMYCIN PO4 2% CREAM,VAG , GLYBURIDE 6MG TAB , ESTROGENS,CONJUGATED 1.25MG TAB , ALPROSTADIL 20MCG/VIL INJ , IBUTILIDE FUMARATE 0.1MG/ML INJ,SOLN , MEDROXYPROGESTERONE ACETATE 104MG/0.65ML INJ,SUSP,SYRINGE , MIGLITOL 25MG TAB , MIGLITOL 50MG TAB , MIGLITOL 100MG TAB , EPIRUBICIN HCL 2MG/ML INJ , LINEZOLID 100MG/5ML SUSP,ORAL , LINEZOLID 2MG/ML INJ,BAG,100ML , LINEZOLID 600MG TAB , LINEZOLID 600MG TAB,UD , LINEZOLID 2MG/ML INJ,BAG,300ML , ALPROSTADIL 10MCG/VIL IMPULSE INJ,SYSTEM , ALPROSTADIL 20MCG/VIL IMPLUSE INJ,SYSTEM , NICOTINE 10MG/CARTRIDGE INHL,ORAL,168/KIT , NICOTINE 10MG/ML SOLN,NASAL SPRAY , PEGVISOMANT PROTEIN 10MG/VIL INJ , PEGVISOMANT PROTEIN 15MG/VIL INJ , PEGVISOMANT PROTEIN 20MG/VIL INJ , PEGVISOMANT PROTEIN 25MG/VIL INJ , PEGVISOMANT PROTEIN 30MG/VIL INJ , ANTI-THYMOCYTE GLOBULIN 50MG/ML INJ,PF , MEDROXYPROGESTERONE ACETATE 150MG/ML INJ,SUSP,SYRINGE,1ML , IRINOTECAN HCL 20MG/ML INJ,SOLN , EXEMESTANE 25MG TAB , CLINDAMYCIN PHOSPHATE 100MG SUPP,VAG , ALPROSTADIL 40MCG/VIL INJ , SULFASALAZINE 500MG TAB , SULFASALAZINE 500MG TAB,EC , ESTRAMUSTINE PO4 SODIUM 140MG CAP , TRANEXAMIC ACID 100MG/ML INJ,AMP,10ML , TRANEXAMIC ACID 100MG/ML INJ, VI,10ML , ESTRADIOL 2MG RING,VAG , IDARUBICIN HCL 1MG/ML (PF) INJ,SOLN , SOMATROPIN 5MG/VIL INJ,INTRA-MIX , SOMATROPIN 12MG/VIL INJ , SOMATROPIN 0.2MG/VIL INJ,MINIQUICK , SOMATROPIN 0.4MG/VIL INJ,MINIQUICK , SOMATROPIN 0.6MG/VIL INJ,MINIQUICK , SOMATROPIN 0.8MG/VIL INJ,MINIQUICK , SOMATROPIN 1MG/VIL INJ,MINIQUICK , SOMATROPIN 1.2MG/VIL INJ,MINIQUICK , SOMATROPIN 1.4MG/VIL INJ,MINIQUICK , SOMATROPIN 1.6MG/VIL INJ,MINIQUICK , SOMATROPIN 1.8MG/VIL INJ,MINIQUICK , SOMATROPIN 2MG/VIL INJ,MINIQUICK , RIFABUTIN 150MG CAP , DEXRAZOXANE HCL 250MG/VIL INJ , ATROPINE SO4 0.025MG/DIPHENOXYLATE HCL 2.5MG TAB , NAFARELIN ACETATE 2MG/ML SOLN,NASAL , SPIRONOLACTONE 25MG TAB , HYDROCHLOROTHIAZIDE 25MG/SPIRONOLACTONE 25MG TAB , HEPARIN NA (PORK) 5000UNT/ML INJ , HYDROCHLOROTHIAZIDE 50MG/SPIRONOLACTONE 50MG TAB , SPIRONOLACTONE 100MG TAB , SPIRONOLACTONE 50MG TAB , OXAPROZIN 600MG TAB , DICLOFENAC NA 50MG/MISOPROSTOL 200MCG TAB , DICLOFENAC NA 75MG/MISOPROSTOL 200MCG TAB , MISOPROSTOL 100MCG TAB , MISOPROSTOL 200MCG TAB , METRONIDAZOLE 500MG TAB , METRONIDAZOLE 250MG TAB , VERAPAMIL HCL 240MG TAB,SA , VERAPAMIL HCL 120MG TAB,SA , VERAPAMIL HCL 180MG TAB,SA , METRONIDAZOLE 375MG CAP , DISOPYRAMIDE PO4 100MG CAP,SA , DISOPYRAMIDE PO4 150MG CAP,SA , DISOPYRAMIDE PO4 100MG CAP , DISOPYRAMIDE PO4 150MG CAP , ESTROGENS,CONJUGATED 5MG/ML INJ,SOLN , ESTROGENS,CONJUGATED 0.625MG/GM CREAM,VAG , ECHOTHIOPHATE IODIDE 0.125% SOLN,OPH , ESTROGENS,CONJUGATED 0.3MG TAB , ESTROGENS,CONJUGATED 0.45MG TAB , ESTROGENS,CONJUGATED 0.625MG TAB , ESTROGENS,CONJUGATED 0.9MG TAB , PREMPRO 0.3MG/1.5MG TAB,28 PACK , PREMPRO 0.45MG/1.5MG TAB,28 PACK , PREMPRO 0.625MG/2.5MG TAB,28 PACK , PREMPRO 0.625MG/5MG TAB,28 PACK , PREMPHASE COMBO BLIS PAK,14+14 , AMPICILLIN NA/SULBACTAM NA 1.5GM/VIL INJ , AMPICILLIN NA/SULBACTAM NA 3GM/VIL INJ , AMPICILLIN NA/SULBACTAM NA 15GM/VIL INJ , ANIDULAFUNGIN 50MG/VIL INJ , ANIDULAFUNGIN 100MG/VIL INJ , GLIPIZIDE 2.5MG TAB,SA , GLIPIZIDE 5MG TAB,SA , GLIPIZIDE 10MG TAB,SA , PENICILLIN G K 5MILLION UNT/VIL INJ , PENICILLIN G K 20MILLION UNT/VIL INJ , VORICONAZOLE 40MG/ML SUSP,ORAL , VORICONAZOLE 50MG TAB , VORICONAZOLE 200MG TAB , VORICONAZOLE 200MG/VIL INJ , FLUCONAZOLE 50MG TAB , FLUCONAZOLE 100MG TAB , FLUCONAZOLE 200MG TAB , FLUCONAZOLE 10MG/ML SUSP,ORAL , FLUCONAZOLE 40MG/ML SUSP,ORAL , FLUCONAZOLE 150MG TAB , GLIPIZIDE 5MG TAB , GLIPIZIDE 10MG TAB , HEPARIN NA 1000UNT/ML (PF) INJ , TALIGLUCERASE ALFA 200 UNIT/VIL INJ , BENZONATATE 100MG CAP , BOSUTINIB 100MG TAB , BOSUTINIB 500MG TAB , HEPARIN NA 1000UNT/ML INJ , AXITINIB 1MG TAB , AXTINIB 5MG TAB , PALBOCICLIB 75MG CAP,ORAL , PALBOCICLIB 100MG CAP,ORAL , PALBOCICLIB 125MG CAP,ORAL , BOSUTINIB 400MG TAB , DALTEPARIN NA 2500UNT/0.2ML SYRINGE , DALTEPARIN NA 5000UNT/0.2ML SYRINGE , DACOMITINIB 15MG TAB , DALTEPARIN NA 7500UNT/0.3ML SYRINGE , DALTEPARIN NA 10000UNT/1ML SYRINGE , DALTEPARIN NA 12500UNT/0.5ML SYRINGE , DALTEPARIN NA 15000UNT/0.6ML SYRINGE , LORLATINIB 25MG TAB , DALTEPARIN NA 18000UNT/0.72ML SYRINGE , LORLATINIB 100MG TAB , DALTEPARIN NA 25000UNT/3.8ML SYRINGE , RITUXIMAB-PVVR 10MG/ML INJ,SOLN , FESOTERODINE FUMARATE 4MG TAB,SA , FESOTERODINE FUMARATE 8MG TAB,SA , PALBOCICLIB 75MG TAB,ORAL , FILGRASTIM-AAFI 600MCG/ML (PF) INJ,SYRINGE,0.5ML , FILGRASTIM-AAFI 600MCG/ML (PF) INJ,SYRINGE,0.8ML , TALAZOPARIB 0.25MG CAP,ORAL , GLASDEGIB 25MG TAB , TRASTUZUMAB-QYYP 420MG/VIAL INJ , MEROPENEM 500MG/VIL INJ , MEROPENEM 1GM/VIL INJ , BEVACIZUMAB-BVZR 25MG/ML INJ,4ML , BEVACIZUMAB-BVZR 25MG/ML INJ,16ML , VARENICLINE TARTRATE 0.5MG TAB , VARENICLINE TARTRATE 1MG TAB,56 , VARENICLINE TARTRATE 1MG TAB , VARENICLINE TARTRATE TAB STARTER PACK,53 , PALBOCICLIB 100MG TAB,ORAL , TOFACITINIB 11MG 24HR TAB,SA , TOFACITINIB CITRATE 22MG 24HR TAB,SA , SUNITINIB MALATE 12.5MG CAP,ORAL , PALBOCICLIB 125MG TAB,ORAL , SUNITINIB MALATE 25MG CAP,ORAL , INFLIXIMAB 100MG/20MLVIL (PF) INJ , SUNITINIB MALATE 37.5MG CAP,ORAL , DOXYCYCLINE HYCLATE 100MG CAP , DOXYCYCLINE MONOHYDRATE 25MG/5ML LIQUID , DOXYCYCLINE CA 50MG/5ML SUSP , SUNITINIB MALATE 50MG CAP,ORAL , TOFACITINIB CITRATE 5MG TAB , TOFACITINIB CITRATE 10MG TAB , GLOBULIN,IMMUNE (IGG)HIPP (SQ) 16.5% INJ , GLOBULIN,IMMUNE (IV) 10% INJ , TALAZOPARIB 1MG CAP,ORAL , DACOMITINIB 30MG TAB , EPOETIN ALFA-EPBX 2000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 3000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 4000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 10000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 40000UNIT/ML INJ,SOLN , GLASDEGIB 100MG TAB , TAFAMIDIS MEGLUMINE 20MG CAP,ORAL , DACOMITINIB 45MG TAB , NIFEDIPINE 10MG CAP , NIFEDIPINE (PROCARDIA XL) 30MG SA TAB , NIFEDIPINE (PROCARDIA XL) 60MG SA TAB , NIFEDIPINE (PROCARDIA XL) 90MG SA TAB , DOXORUBICIN HCL 2MG/ML VIL,INJ , AZITHROMYCIN 1GM/PKT PWDR,ORAL , AZITHROMYCIN 250MG TAB , AZITHROMYCIN 250MG TAB,PKT,6 , AZITHROMYCIN 500MG TAB , AZITHROMYCIN 500MG TAB,PKT,3 , AZITHROMYCIN 100MG/5ML SUSP,ORAL , AZITHROMYCIN 200MG/5ML SUSP,ORAL , AZITHROMYCIN DIHYDRATE 500MG/VIL INJ , PIROXICAM 10MG CAP , PIROXICAM 20MG CAP , PRAZOSIN HCL 1MG CAP , PRAZOSIN HCL 2MG CAP , PRAZOSIN HCL 5MG CAP , HYDROXYZINE PAMOATE 25MG CAP , HYDROXYZINE PAMOATE 50MG CAP , METAXALONE 800MG TAB , DOFETILIDE 125MCG CAP,UD , DOFETILIDE 125MCG CAP , DOFETILIDE 250MCG CAP,UD , DOFETILIDE 250MCG CAP , DOFETILIDE 500MCG CAP,UD , DOFETILIDE 500MCG CAP , FOSPHENYTOIN NA 50MG-PE/10ML INJ , FOSPHENYTOIN NA 100MG-PE/2ML INJ , CRIZ0TINIB 250MG CAP , CRIZ0TINIB 200MG CAP , TAFAMIDIS 61MG CAPSULE , HYDROCHLOROTHIAZIDE 12.5MG/QUINAPRIL HCL 20MG TAB , HYDROCHLOROTHIAZIDE 12.5MG/QUINAPRIL HCL 10MG TAB , HYDROCHLOROTHIAZIDE 25MG/QUINAPRIL HCL 20MG TAB , ETHOSUXIMIDE 250MG CAP , PHENELZINE SO4 15MG TAB , METHSUXIMIDE 300MG CAP , QUINAPRIL HCL 5MG TAB , QUINAPRIL HCL 10MG TAB , QUINAPRIL HCL 20MG TAB , QUINAPRIL HCL 40MG TAB , GEMFIBROZIL 600MG TAB , ETHOSUXIMIDE 250MG/5ML SYRUP , PIPERACILLIN NA 2GM/TAZOBACTAM NA 0.25GM/50ML INJ,BAG,50ML , PIPERACILLIN NA 3GM/TAZOBACTAM 0.375GM/50ML INJ,BAG,50ML , PIPERACILLIN NA 4GM/TAZOBACTAM NA 0.5GM/100ML INJ,BAG,100ML , CRISABOROLE 2% OINT,TOP , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 250IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 500IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 1000IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 2000IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT 3000UNT/VIL INJ , ANTIHEMOPHILIC FACTOR,RECOMBINANT 1000UNT/VIL INJ , ANTIHEMOPHILIC FACTOR,RECOMBINANT 2000UNT/VIL INJ , FACTOR IX,RECOMBINANT 250 UNT/VIL INJ , FACTOR IX,RECOMBINANT 500 UNT/VIL INJ , FACTOR IX,RECOMBINANT 1000 UNT/VIL INJ , FACTOR IX/RECOMBINANT 2000 UNT/VIL INJ , FACTOR IX/RECOMBINANT 3000 UNT/VIL INJ , LIOTHYRONINE NA 5MCG TAB , LIOTHYRONINE NA 25MCG TAB , LIOTHYRONINE NA 50MCG TAB , PENICILLIN G PROCAINE 600000UNT/ML INJ,SUSP , DICLOFENAC EPOLAMINE 1.3% PATCH , THROMBIN 5000UNT/VIL SOLN,NASAL,KIT W/SYRINGE , THROMBIN 5000UNT/VIL PWDR,TOP , THROMBIN 20000UNT/VIL PWDR,TOP , PEN G BENZATHINE 300000UNT/PEN G PROCAINE 300000UNT/ML INJ,SUSP , PEN G BENZATHINE 450000UNT/PEN G PROCAINE 150000UNT/ML INJ,SUSP , PENICILLIN G BENZATHINE 600000UNT/ML INJ,SUSP , THROMBIN 5000UNIT/VIL (BOVINE) SPRAY, TOP KIT , LEVOTHYROXINE NA 25MCG TAB , LEVOTHYROXINE NA 50MCG TAB , LEVOTHYROXINE NA 75MCG TAB , LEVOTHYROXINE NA 88MCG TAB , LEVOTHYROXINE NA 100MCG TAB , LEVOTHYROXINE NA 112MCG TAB , LEVOTHYROXINE NA 125MCG TAB , LEVOTHYROXINE NA 137MCG TAB , LEVOTHYROXINE NA 150MCG TAB , LEVOTHYROXINE NA 175MCG TAB , LEVOTHYROXINE NA 200MCG TAB , B-TRACIN 400UNT/HC 1%/N-MYCIN 5MG/POLYMYX 5000UNT/GM OINT,TOP , HC 0.5%/N-MYCIN 3.5MG/POLYMYX 10000UNIT/GM CREAM,TOP , TRIMETHOBENZAMIDE HCL 300MG CAP , RAMIPRIL 1.25MG CAP , RAMIPRIL 2.5MG CAP , RAMIPRIL 5MG CAP , RAMIPRIL 10MG CAP , SILVER SULFADIAZINE 1% CREAM,TOP , DALFOPRISTIN 350MG/QUINUPRISTIN 150MG/VIL INJ , BEVACIZUMAB-BVZR 25MG/ML, 4ML INJ , BEVACIZUMAB-BVZR 25MG/ML, 16ML INJ

Shared Drug Filings

41

Filings
See more under details

FDA Drug Shortage

3

Listed
Currently in Shortage 1
Drug Shortage Resolved 1
Drug to be Discontinued 1

FDA Production Site Inspection Outcomes since 2019

8 / 0

2019 / 2020 Inspections
No Action Indicated:
Pfizer Boulder - Boulder - CO - US - 2019-12-20
Pfizer Inc - Chesterfield - MO - US - 2019-08-20
Pfizer Clinical Research Unit - New Haven - CT - US - 2019-06-14
Pfizer Clinical Research Unit, Hopital Erasme - Anderlecht - - BE - 2019-04-12

Voluntary Action Indicated:
Pfizer Manufacturing Deutschland GmbH - Freiburg im Breisgau - - DE - 2019-03-08
Pfizer Ireland Pharmaceuticals - Newbridge - - IE - 2019-09-27
Pfizer Pharmaceuticals LLC - Barceloneta - PR - US - 2019-12-20

Official Action Indicated:
Pfizer Healthcare India Private Limited - Visakhapatnam - - IN - 2019-09-06

Recent FDA Recalls (Abridged)

23

Recent Recalls
Pfizer Inc - Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028. - Lack of Assurance of Sterility: Bags have the potential to leak.
58200 bags, 20190724

Pfizer Inc - Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233. - Lack of Assurance of Sterility: Bags have the potential to leak.
280340 bags, 20190724

Pfizer Inc - Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24 - Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
7,686 100-count bottles, 20191002

Pfizer Inc - Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12 - Failed Dissolution Specifications
544400 packages, 20200701

Pfizer Inc - Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017. - Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
100277 tablets, 20190522

Pfizer Inc - Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
67 cartons (25 vials per carton), 20190410

Pfizer Inc - Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
820 cartons (25 vials per carton), 20190410

Pfizer Inc - Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
500 cartons (25 vials per carton), 20190410

Pfizer Inc - Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
701 cartons (25 vials per carton), 20190410

Pfizer Inc - Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
8,878 cartons (25 vials per carton), 20190410

Pfizer Inc - Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03 - Lack of Assurance of Sterility
185,700 vials, 20190918

Pfizer Inc - RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017. - Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
a) 20,117 cartons; b) 2,502 cartons, 20190904

Pfizer Inc - Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray). - Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
38,676 trays, 20200219

Pfizer Inc - Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
8,320 cartons (25 vials per carton), 20190410

Pfizer Inc - Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12 - Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
19,144 vials, 20200812

Pfizer Inc - Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30. - Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
141 bottles, 20200219

Pfizer Inc - 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10 - Labeling: Incorrect or Missing Lot and/or expiration date.
77,100 syringes, 20191218

Pfizer Inc - Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30. - Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
128 bottles, 20200219

Pfizer Inc - Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83 - Presence of Particulate Matter: particulate matter identified after reconstitution.
94320 units, 20200617

Pfizer Inc - ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2 - Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
7,824 100-count bottles, 20191002

Pfizer Inc - Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01 - Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
24,714 vials, 20200311

Pfizer Inc - 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13 - Lack of Assurance of Sterility: Bag has the potential to leak.
17832 bags, 20191016

Pfizer Inc - 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02 - Presence of Particulate Matter; glass particulates
283,400 vials, 20190410

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Did you know that sometimes those letters even include secrets like drug expiry shelf life and the API suppliers?


Wizmed does and links up the FDA letters by drug NDC and you can access it in the details of a drug page, See Example . If that was not enough for your to use Wizmed. We even use fuzzy lookups to make estimations on which FDA registered locations are making active pharmaceutical ingredients to drive some insight into where your pharmaceuticals are made.

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