FDA Drug NDCs and Drug Labels for dexmedetomidine

Manufacturer Route Drug Strength NDCs Type Application Holder Approval Date PI / Labels / Letters
Sandoz Inc. intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 0781-3494-95 ANDA JIANGSU HENGRUI MED 2020-06-12
Baxter Healthca ━ NovaPlus intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 400 ug/100mL 43066-557-12 ANDA BAXTER HLTHCARE CORP 2019-08-27
Baxter Healthca ━ NovaPlus ━ Premier ProRx intravenous dexmedetomidine hydrochloride 400 ug/100mL 43066-565-12 ANDA BAXTER HLTHCARE CORP 2019-08-27
Baxter Healthca intravenous dexmedetomidine hydrochloride 400 ug/100mL 0338-9557-12 ANDA BAXTER HLTHCARE CORP 2018-08-21
Mylan Instituti intravenous dexmedetomidine 100 ug/mL 67457-251-02 ANDA MYLAN INSTITUTIONAL 2014-08-18
Slayback Pharma intravenous dexmedetomidine hydrochloride 4 ug/mL 71225-126-05, 71225-126-06 ANDA SLAYBACK PHARMA LLC 2019-12-06
Medical Purchas intravenous dexmedetomidine hydrochloride 100 ug/mL 71872-7031-1 ANDA AUROBINDO PHARMA LTD 2016-03-17
CIVICA, INC. intravenous dexmedetomidine hydrochloride 4 ug/mL 72572-127-10 ANDA SLAYBACK PHARMA LLC 2021-08-23
Hikma Pharmaceu intravenous dexmedetomidine hydrochloride 4 ug/mL 0143-9525-10 ANDA HIKMA 2020-01-30
Dr.Reddy's Labo intravenous dexmedetomidine hydrochloride 4 ug/mL 43598-975-58 ANDA GLAND PHARMA LTD 2020-08-17
Precision Dose, intravenous dexmedetomidine hydrochloride 4 ug/mL 68094-147-20 ANDA TAGI 2020-11-23
Hospira, Inc. intravenous dexmedetomidine hydrochloride 4 ug/mL 0409-1660-10, 0409-1660-20, 0409-1660-50 NDA HOSPIRA 2013-04-08
Medical Purchas intravenous dexmedetomidine hydrochloride 100 ug/mL 71872-7030-1 ANDA ACCORD HLTHCARE 2016-12-21
Akorn, Inc. intravenous dexmedetomidine hydrochloride 100 ug/mL 17478-055-02 ANDA AKORN 2014-11-24
Par Pharmaceuti intravenous dexmedetomidine hydrochloride 4 ug/mL 42023-187-10 ANDA PAR STERILE PRODUCTS 2020-12-04
Dr.Reddy's Labo intravenous dexmedetomidine hydrochloride 4 ug/mL 43598-976-58 ANDA GLAND PHARMA LTD 2020-08-17
WG Critical Car intravenous dexmedetomidine hydrochloride 4 ug/mL 44567-602-24 NDA HQ SPCLT PHARMA 2016-04-19
AuroMedics Phar intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 55150-296-10 ANDA AUROBINDO PHARMA LTD 2020-12-07
Fresenius Kabi intravenous dexmedetomidine hydrochloride 4 ug/mL 63323-671-00, 63323-671-20, 63323-671-50 ANDA FRESENIUS KABI USA 2019-05-13
Amneal Pharmace intravenous dexmedetomidine hydrochloride 4 ug/mL 70121-1388-8 ANDA AMNEAL PHARMS CO 2020-05-20
Accord Healthca intravenous dexmedetomidine 100 ug/mL 16729-239-93 ANDA ACCORD HLTHCARE 2016-12-21
Accord Healthca ━ NovaPlus intravenous dexmedetomidine 100 ug/mL 16729-432-93 ANDA ACCORD HLTHCARE 2018-08-31
Hikma Pharmaceu intravenous dexmedetomidine hydrochloride 4 ug/mL 0143-9526-10 ANDA HIKMA 2020-01-30
Hikma Pharmaceu intravenous dexmedetomidine hcl 100 ug/mL 0143-9532-25 ANDA HIKMA 2017-04-26
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-115-20 ANDA TAGI 2020-11-23
AuroMedics Phar intravenous dexmedetomidine 100 ug/mL 55150-209-02 ANDA AUROBINDO PHARMA LTD 2016-03-17
Fresenius Kabi intravenous dexmedetomidine hydrochloride 100 ug/mL 63323-421-02 ANDA FRESENIUS KABI USA 2015-09-18
Piramal Critica intravenous dexmedetomidine hydrochloride 4 ug/mL 66794-234-44 ANDA GLAND PHARMA LTD 2021-04-01
Gland Pharma Li intravenous dexmedetomidine hydrochloride 4 ug/mL 68083-239-10 ANDA GLAND PHARMA LTD 2020-06-03
Athenex Pharmac intravenous dexmedetomidine 100 ug/mL 70860-605-02, 70860-605-03 ANDA JIANGSU HENGRUI MED 2018-03-01
CIVICA, INC. intravenous dexmedetomidine hydrochloride 4 ug/mL 72572-128-08 ANDA SLAYBACK PHARMA LLC 2021-08-23
WG Critical Car intravenous dexmedetomidine hydrochloride 100 ug/mL 44567-601-04 NDA HQ SPCLT PHARMA 2016-04-19
AuroMedics Phar intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 55150-297-10 ANDA AUROBINDO PHARMA LTD 2020-12-07
Piramal Critica intravenous dexmedetomidine 200 ug/2mL 66794-230-42 ANDA GLAND 2021-01-19
Mylan Instituti intravenous dexmedetomidine hydrochloride 200 ug/50mL 67457-924-50 ANDA MYLAN LABS LTD 2020-11-13
Hospira, Inc. intravenous dexmedetomidine hydrochloride 4 ug/mL 0409-1434-01 NDA HOSPIRA 2020-09-28
Medical Purchas intravenous dexmedetomidine 100 ug/mL 71872-7150-1 ANDA JIANGSU HENGRUI MED 2018-03-01
Sandoz Inc. intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 0781-3495-95 ANDA JIANGSU HENGRUI MED 2020-06-12
Baxter Healthca ━ NovaPlus ━ Premier ProRx intravenous dexmedetomidine hydrochloride 200 ug/50mL 43066-561-24 ANDA BAXTER HLTHCARE CORP 2019-08-27
Piramal Critica intravenous dexmedetomidine 100 ug/mL 66794-238-41, 66794-238-43 ANDA 2020-04-24
Precision Dose, intravenous dexmedetomidine hydrochloride 4 ug/mL 68094-047-10 ANDA TAGI 2020-11-23
Hospira, Inc. intravenous dexmedetomidine hydrochloride 100 ug/mL 0409-1638-02 NDA HOSPIRA 2004-11-30
Par Pharmaceuti intravenous dexmedetomidine hydrochloride 100 ug/mL 42023-146-25 ANDA PAR STERILE PRODUCTS 2014-08-19
Baxter Healthca ━ NovaPlus intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 200 ug/50mL 43066-555-24 ANDA BAXTER HLTHCARE CORP 2019-08-27
Sun Pharmaceuti intravenous dexmedetomidine hydrochloride 100 ug/mL 57664-596-50 ANDA GLAND 2015-04-08
Baxter Healthca intravenous dexmedetomidine hydrochloride 200 ug/50mL 0338-9555-24 ANDA BAXTER HLTHCARE CORP 2018-08-21
Gland Pharma Li intravenous dexmedetomidine hydrochloride 4 ug/mL 68083-238-20 ANDA GLAND PHARMA LTD 2020-06-03
Precision Dose, intravenous dexmedetomidine hydrochloride 4 ug/mL 68094-247-10 ANDA TAGI 2020-11-23
Zydus Pharmaceu intravenous dexmedetomidine hydrochloride 100 ug/mL 68382-124-25 ANDA ZYDUS PHARMS 2018-06-14
Medical Purchas intravenous dexmedetomidine hcl 100 ug/mL 71872-7218-1 ANDA HIKMA 2017-04-26
Sandoz Inc. intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 0781-3493-95 ANDA JIANGSU HENGRUI MED 2020-06-12
Par Pharmaceuti intravenous dexmedetomidine hydrochloride 4 ug/mL 42023-186-20 ANDA PAR STERILE PRODUCTS 2020-12-04
WG Critical Car intravenous dexmedetomidine hydrochloride 4 ug/mL 44567-603-24 NDA HQ SPCLT PHARMA 2016-04-19
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-015-10 ANDA TAGI 2020-11-23
Piramal Critica intravenous dexmedetomidine 200 ug/2mL 66794-233-42 ANDA GLAND 2021-05-01
Mylan Instituti intravenous dexmedetomidine hydrochloride 400 ug/100mL 67457-925-10 ANDA MYLAN LABS LTD 2020-11-13
Amneal Pharmace intravenous dexmedetomidine hydrochloride 4 ug/mL 70121-1389-7 ANDA AMNEAL PHARMS CO 2020-05-20
WG Critical Car intravenous dexmedetomidine hydrochloride 100 ug/mL 44567-600-04 NDA HQ SPCLT PHARMA 2016-04-19
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-215-10 ANDA TAGI 2020-11-23
General Injecta intravenous dexmedetomidine hydrochloride 100 ug/mL 52584-638-02 NDA HOSPIRA 2018-07-02
Piramal Critica intravenous dexmedetomidine hydrochloride 4 ug/mL 66794-235-41 ANDA GLAND PHARMA LTD 2021-04-01
Meitheal Pharma intravenous dexmedetomidine 100 ug/mL 71288-505-03 ANDA HONG KONG 2019-01-18
Medical Purchas intravenous dexmedetomidine hydrochloride 100 ug/mL 71872-7122-1 ANDA GLAND 2015-04-08
Cadila Healthca intravenous dexmedetomidine hydrochloride 100 ug/mL 70771-1319-7 ANDA ZYDUS PHARMS 2018-06-14
ACTAVIS INC injection dexmedetomidine hydrochloride EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) ANDA 1970-01-01
SANDOZ INC injection dexmedetomidine hydrochloride EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) ANDA 1970-01-01
TEVA PHARMACEUT injection dexmedetomidine hydrochloride EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) ANDA 1970-01-01
Filing Details
NDA Filings
Hospira, , WG Critic , General I
ANDAs (Approved New Drug Applications)
Sandoz In , Baxter He , Mylan Ins , Slayback , Medical P , CIVICA, I , Hikma Pha , Dr.Reddy' , Precision , Akorn, In , Par Pharm , AuroMedic , Fresenius , Amneal Ph , Accord He , TAGI Phar , Piramal C , Gland Pha , Athenex P , Sun Pharm , Zydus Pha , Meitheal , Cadila He , ACTAVIS I , TEVA PHAR
Private Labels

NovaPlus
Baxter Healthcare Corporation - DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE - INTRAVENOUS - 43066-557-12 - 400 ug/100mL

NovaPlus
Baxter Healthcare Corporation - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 43066-565-12 - 400 ug/100mL

NovaPlus
Accord Healthcare Inc. - DEXMEDETOMIDINE - INTRAVENOUS - 16729-432-93 - 100 ug/mL

NovaPlus
Baxter Healthcare Corporation - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 43066-561-24 - 200 ug/50mL

NovaPlus
Baxter Healthcare Corporation - DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE - INTRAVENOUS - 43066-555-24 - 200 ug/50mL

SLAYBACK PHARMA LLC - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 72572-127-10 - 4 ug/mL
SLAYBACK PHARMA LLC - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 72572-128-08 - 4 ug/mL
Schein
HOSPIRA - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 52584-638-02 - 100 ug/mL