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FDA Drug NDCs and Drug Labels
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FDA Drug NDCs / Labels

162

Total Labels
NDA Filings Hydromorp , Dextrose , Calcium A , MAGNESIUM , Fish oil , LIDOCAINE , PROPOFOL , TOBRAMYCI , BUPIVACAI , HEPARIN S , Atropine , MOXIFLOXA , Morphine , PENTAMIDI , Neostigmi , Anticoagu , INDOMETHA , Dextrose, , Levothyro , Tigecycli , ROPIVACAI , Caspofung , CHLOROPRO , Argatroba , Bortezomi , Smoflipid , iron sucr , Daptomyci , Potassium , LINEZOLID , FUROSEMID , Glucagon , clevidipi , Fulvestra , sucroferr , OXYTOCIN , Calcium G , ACETAMINO , PALONOSET
Authorized Generic Drugs enoxapari , Calcium A
ANDAs (Approved New Drug Applications) GENTAMICI , GEMCITABI , CISPLATIN , MAGNESIUM , FLUOROURA , DACARBAZI , MITOXANTR , KETOROLAC , DEXAMETHA , CEFAZOLIN , METHYLPRE , VINBLASTI , CLINDAMYC , Vancomyci , Piperacil , ACYCLOVIR , NAFCILLIN , Cefepime , Imipenem , POLYMYXIN , OCTREOTID , AZITHROMY , AZTREONAM , BUPIVACAI , Enoxapari , HYDRALAZI , SODIUM CH , CHLOROTHI , DIPHENHYD , ACETYLCYS , Paclitaxe , Ertapenem , Dicyclomi , BENZTROPI , ampicilli , Lactulose , THIAMINE , DOXYCYCLI , CLADRIBIN , PROGESTER , TOBRAMYCI , Cefoxitin , LEVETIRAC , VALPROATE , Meropenem , AMIODARON , Palonoset , FAMOTIDIN , Azacitidi , Methocarb , POTASSIUM , Heparin S , CHLORAMPH , CYANOCOBA , METHOTREX , LIDOCAINE , LEVOFLOXA , Daptomyci , CEFOTETAN , MIDAZOLAM , CISATRACU , Dexmedeto , Bivalirud , Glycopyrr , Leucovori , ADENOSINE , Linezolid , Remifenta , MESNA , Dextrose , Metoclopr , ONDANSETR , SODIUM AC , Folic Aci , FLUDARABI , PROTAMINE , MEPIVACAI , GRANISETR , COLISTIME , HALOPERID , clofarabi , DEFEROXAM , TERBUTALI , Micafungi , TOPOTECAN , Zoledroni , ETOPOSIDE , CYTARABIN , FLOXURIDI , FLUPHENAZ , GANCICLOV , ESMOLOL H , Decitabin , DOXORUBIC , FOSAPREPI , MANNITOL , BLEOMYCIN , IFOSFAMID , Ceftriaxo , Dimenhydr , METOPROLO , Fentanyl , Amikacin , WATER , RIFAMPIN , ROCURONIU , MILRINONE , Oxaliplat , Phenyleph , IRINOTECA , Sumatript , FOSPHENYT , Tranexami , Arsenic T , Melphalan , Vecuroniu , Busulfan , PYRIDOXIN , BACITRACI , CAFFEINE , FLUMAZENI , PROPRANOL , CARBOPLAT , CLONIDINE , DAUNORUBI , DEXTROSE; , DIPYRIDAM , EPIRUBICI , FLUCONAZO , IDARUBICI , OXACILLIN , PAMIDRONA , VINORELBI , ICATIBANT , EPHEDRINE , ANASTROZO
Unapproved Drugs hydroxypr , SODIUM CH , WATER , SODIUM GL , SODIUM PH , POTASSIUM , PROPOFOL
BLA Chorionic
Vertically Integrated (estimated) lactulo, paclita, irinote, oxalipl, ceftria, anastro, gemcita, ampicil, busulfa, decitab, piperac, ropivac, cefepim,
Private labels
NovaPlus Fresenius Kabi USA, LLC - GENTAMICIN SULFATE - INTRAMUSCULAR, INTRAVENOUS - 63323-010-96 - 40 mg/mL
NovaPlus Fresenius Kabi USA, LLC - FLUOROURACIL - INTRAVENOUS - 63323-117-59, 63323-117-69 - 50 mg/mL
NovaPlus Fresenius Kabi USA, LLC - KETOROLAC TROMETHAMINE - INTRAMUSCULAR - 63323-162-12, 63323-162-14 - 30 mg/mL
Premier Fresenius Kabi, LLC - Vancomycin Hydrochloride - INTRAVENOUS - 63323-284-45 - 1 g/20mL
Schein FRESENIUS KABI USA - CALCIUM GLUCONATE - INTRAVENOUS - 51662-1312-1 - 98 mg/mL
Schein FRESENIUS KABI USA - CHLOROPROCAINE HCI - EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL - 51662-1408-1 - 20 mg/mL
Schein FRESENIUS KABI USA - LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE - EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL - 51662-1412-1 - .005 mg/mL, 20 mg/mL
Schein FRESENIUS KABI USA - Midazolam - INTRAMUSCULAR, INTRAVENOUS - 52584-081-13 - 1 mg/mL

FDA Drug NDCs and Drug Labels Developed through combinations of orange book, dailymed and openFDA

Drug Manufacturer Route Strength NDCs Type Application Holder Approval Date PI / Labels
hydromorphone hydrochloride Fresenius Kabi intramuscular, intravenous, subcutaneous 2 mg/mL 76045-010-11 NDA FRESENIUS KABI USA 1994-08-04
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride Fresenius Medic intraperitoneal 1.5 g/100mL, 538 mg/100mL, 448 mg/100mL, 18.4 mg/100mL, 5.08 mg/100mL 49230-206-20, 49230-206-30, 49230-206-32, 49230-206-50, 49230-206-60, 49230-206-62 NDA FRESENIUS MEDCL 1992-08-19
calcium acetate Fresenius Medic oral 667 mg/1 49230-640-21 NDA FRESENIUS MEDCL 2001-04-02
gentamicin sulfate Fresenius Kabi ━ NovaPlus intramuscular, intravenous 40 mg/mL 63323-010-96 ANDA FRESENIUS KABI USA 1983-08-04