FDA Drug NDCs and Drug Labels for dexmedetomidine

Manufacturer Route Drug Strength NDCs Type Application Holder Approval Date PI / Labels / Letters
Hikma Pharmaceu intravenous dexmedetomidine hydrochloride 4 ug/mL 0143-9525-10 ANDA HIKMA 2020-01-30
WG Critical Car intravenous dexmedetomidine hydrochloride 100 ug/mL 44567-601-04 NDA HQ SPCLT PHARMA 2018-06-22
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-215-10 ANDA TAGI 2020-11-23
AuroMedics Phar intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 55150-297-10 ANDA EUGIA PHARMA 2016-03-17
Sun Pharmaceuti intravenous dexmedetomidine hydrochloride 100 ug/mL 57664-596-50 ANDA GLAND 2015-08-20
Gland Pharma Li intravenous dexmedetomidine hydrochloride 4 ug/mL 68083-239-10 ANDA GLAND PHARMA LTD 2020-06-03
Precision Dose, intravenous dexmedetomidine hydrochloride 4 ug/mL 68094-147-20 ANDA TAGI 2020-11-23
Hospira, Inc. intravenous dexmedetomidine hydrochloride 4 ug/mL 0409-1174-10 NDA HOSPIRA 2022-03-07
Par Pharmaceuti intravenous dexmedetomidine hydrochloride 4 ug/mL 42023-187-10 ANDA PAR STERILE PRODUCTS 2014-08-18
General Injecta intravenous dexmedetomidine hydrochloride 100 ug/mL 52584-638-02 NDA HOSPIRA 2013-03-13
Baxter Healthca intravenous dexmedetomidine hydrochloride 400 ug/100mL 0338-9557-12 ANDA BAXTER HLTHCARE CORP 2018-08-21
Piramal Critica intravenous dexmedetomidine hydrochloride 4 ug/mL 66794-234-44 ANDA GLAND PHARMA LTD 2020-06-03
Amneal Pharmace intravenous dexmedetomidine hydrochloride 4 ug/mL 70121-1389-7 ANDA AMNEAL PHARMS CO 2020-05-20
Hospira, Inc. intravenous dexmedetomidine hydrochloride 100 ug/mL 0409-1638-02 NDA HOSPIRA 2013-03-13
CIVICA, INC. intravenous dexmedetomidine hydrochloride 4 ug/mL 72572-127-10 ANDA SLAYBACK PHARMA LLC 2019-12-04
BioXcel Therape sublingual dexmedetomidine 180 ug/1 81092-1180-1, 81092-1180-3 NDA BIOXCEL 2022-07-01
Akorn intravenous dexmedetomidine hydrochloride 100 ug/mL 17478-055-02 ANDA AKORN 2014-11-24
Dr.Reddy's Labo intravenous dexmedetomidine hydrochloride 4 ug/mL 43598-976-58 ANDA GLAND PHARMA LTD 2020-06-03
WG Critical Car intravenous dexmedetomidine hydrochloride 4 ug/mL 44567-602-24 NDA HQ SPCLT PHARMA 2018-06-22
WG Critical Car intravenous dexmedetomidine hydrochloride 4 ug/mL 44567-603-24 NDA HQ SPCLT PHARMA 2018-06-22
Baxter Healthca intravenous dexmedetomidine hydrochloride 200 ug/50mL 0338-9555-24 ANDA BAXTER HLTHCARE CORP 2018-08-21
Precision Dose, intravenous dexmedetomidine hydrochloride 4 ug/mL 68094-047-10 ANDA TAGI 2020-11-23
CIVICA, INC. intravenous dexmedetomidine hydrochloride 4 ug/mL 72572-128-08 ANDA SLAYBACK PHARMA LLC 2019-12-04
Baxter Healthca ━ NovaPlus intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 400 ug/100mL 43066-557-12 ANDA BAXTER HLTHCARE CORP 2018-08-21
Dr.Reddy's Labo intravenous dexmedetomidine hydrochloride 4 ug/mL 43598-975-58 ANDA GLAND PHARMA LTD 2020-06-03
Piramal Critica intravenous dexmedetomidine 200 ug/2mL 66794-230-42 ANDA GLAND 2015-08-20
Piramal Critica ━ NovaPlus intravenous dexmedetomidine 200 ug/2mL 66794-233-42 ANDA GLAND 2015-08-20
Mylan Instituti intravenous dexmedetomidine 100 ug/mL 67457-251-02 ANDA MYLAN INSTITUTIONAL 2014-08-18
Medical Purchas intravenous dexmedetomidine hydrochloride 100 ug/mL 71872-7030-1 ANDA ACCORD HLTHCARE 2016-02-09
Medical Purchas intravenous dexmedetomidine hcl 100 ug/mL 71872-7218-1 ANDA HIKMA 2017-04-26
Accord Healthca ━ NovaPlus intravenous dexmedetomidine 100 ug/mL 16729-432-93 ANDA ACCORD HLTHCARE 2016-02-09
Fresenius Kabi intravenous dexmedetomidine hydrochloride 100 ug/mL 63323-421-02 ANDA FRESENIUS KABI USA 2015-09-18
Henry Schein, I intravenous dexmedetomidine hydrochloride 100 ug/mL 0404-9938-02 NDA HOSPIRA 2013-03-13
Slayback Pharma intravenous dexmedetomidine hydrochloride 4 ug/mL 71225-126-04, 71225-126-05, 71225-126-06 ANDA SLAYBACK PHARMA LLC 2019-12-04
BioXcel Therape sublingual dexmedetomidine 120 ug/1 81092-1120-1, 81092-1120-3 NDA BIOXCEL 2022-07-01
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-115-20 ANDA TAGI 2020-11-23
AuroMedics Phar intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 55150-296-10 ANDA EUGIA PHARMA 2016-03-17
Mylan Instituti intravenous dexmedetomidine hydrochloride 200 ug/50mL 67457-924-50 ANDA MYLAN LABS LTD 2020-08-27
Gland Pharma Li intravenous dexmedetomidine hydrochloride 4 ug/mL 68083-238-20 ANDA GLAND PHARMA LTD 2020-06-03
Hospira, Inc. intravenous dexmedetomidine hydrochloride 4 ug/mL 0409-1434-01 NDA HOSPIRA 2013-03-13
Sandoz Inc. intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 0781-3495-95 ANDA JIANGSU PHARMS 2020-06-12
Accord Healthca intravenous dexmedetomidine 100 ug/mL 16729-239-93 ANDA ACCORD HLTHCARE 2016-02-09
Baxter Healthca ━ NovaPlus intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 200 ug/50mL 43066-555-24 ANDA BAXTER HLTHCARE CORP 2018-08-21
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 2018-02-27
Athenex Pharmac intravenous dexmedetomidine 100 ug/mL 70860-605-02, 70860-605-03 ANDA JIANGSU PHARMS 2020-06-12
Slayback Pharma intravenous dexmedetomidine hydrochloride 4 ug/mL 71225-132-02 ANDA SLAYBACK PHARMA LLC 2019-12-04
Hospira, Inc. intravenous dexmedetomidine hydrochloride 4 ug/mL 0409-3301-10 NDA HOSPIRA 2022-03-07
Medical Purchas intravenous dexmedetomidine hydrochloride 100 ug/mL 71872-7031-1 ANDA EUGIA PHARMA 2016-03-17
Medical Purchas intravenous dexmedetomidine hydrochloride 100 ug/mL 71872-7122-1 ANDA GLAND 2015-08-20
Medical Purchas intravenous dexmedetomidine 100 ug/mL 71872-7150-1 ANDA JIANGSU PHARMS 2020-06-12
Sandoz Inc. intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 0781-3493-95 ANDA JIANGSU PHARMS 2020-06-12
Sandoz Inc. intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 0781-3494-95 ANDA JIANGSU PHARMS 2020-06-12
Hikma Pharmaceu intravenous dexmedetomidine hcl 100 ug/mL 0143-9532-25 ANDA HIKMA 2017-04-26
WG Critical Car intravenous dexmedetomidine hydrochloride 100 ug/mL 44567-600-04 NDA HQ SPCLT PHARMA 2018-06-22
AuroMedics Phar intravenous dexmedetomidine 100 ug/mL 55150-209-02 ANDA EUGIA PHARMA 2016-03-17
Piramal Critica intravenous dexmedetomidine 100 ug/mL 66794-238-41, 66794-238-43 ANDA PIRAMAL CRITICAL 2021-09-03
Mylan Instituti intravenous dexmedetomidine hydrochloride 400 ug/100mL 67457-925-10 ANDA MYLAN LABS LTD 2020-08-27
Meitheal Pharma intravenous dexmedetomidine 100 ug/mL 71288-505-03 ANDA MEITHEAL 2019-01-18
Hospira, Inc. intravenous dexmedetomidine hydrochloride 4 ug/mL 0409-1660-10, 0409-1660-20, 0409-1660-50 NDA HOSPIRA 2013-03-13
Piramal Critica intravenous dexmedetomidine hydrochloride 4 ug/mL 66794-235-41 ANDA GLAND PHARMA LTD 2020-06-03
Amneal Pharmace intravenous dexmedetomidine hydrochloride 4 ug/mL 70121-1388-8 ANDA AMNEAL PHARMS CO 2020-05-20
Cadila Healthca intravenous dexmedetomidine hydrochloride 100 ug/mL 70771-1319-7 ANDA ZYDUS PHARMS 2018-02-27
Slayback Pharma intravenous dexmedetomidine hydrochloride 4 ug/mL 71225-133-02 ANDA SLAYBACK PHARMA LLC 2019-12-04
Par Pharmaceuti intravenous dexmedetomidine hydrochloride 100 ug/mL 42023-146-25 ANDA PAR STERILE PRODUCTS 2014-08-18
Par Pharmaceuti intravenous dexmedetomidine hydrochloride 4 ug/mL 42023-186-20 ANDA PAR STERILE PRODUCTS 2014-08-18
Hikma Pharmaceu intravenous dexmedetomidine hydrochloride 4 ug/mL 0143-9526-10 ANDA HIKMA 2020-01-30
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-015-10 ANDA TAGI 2020-11-23
Fresenius Kabi intravenous dexmedetomidine hydrochloride 4 ug/mL 63323-671-00, 63323-671-20, 63323-671-50 ANDA FRESENIUS KABI USA 2018-11-29
ACTAVIS INC injection dexmedetomidine hydrochloride EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) ANDA 2016-10-17
SANDOZ INC injection dexmedetomidine hydrochloride EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) ANDA 2016-06-14
TEVA PHARMACEUT injection dexmedetomidine hydrochloride EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) ANDA 2017-11-28
Filing Details
NDA Filings
WG Critic , Hospira, , General I , BioXcel T , Henry Sch
ANDAs (Approved New Drug Applications)
Hikma Pha , TAGI Phar , AuroMedic , Sun Pharm , Gland Pha , Precision , Par Pharm , Baxter He , Piramal C , Amneal Ph , CIVICA, I , Akorn , Dr.Reddy' , Mylan Ins , Medical P , Accord He , Fresenius , Slayback , Sandoz In , Zydus Pha , Athenex P , 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
Piramal Critical Care Inc - DEXMEDETOMIDINE - INTRAVENOUS - 66794-233-42 - 200 ug/2mL

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

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

Civica
SLAYBACK PHARMA LLC - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 72572-127-10 - 4 ug/mL

Civica
SLAYBACK PHARMA LLC - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 72572-128-08 - 4 ug/mL

Schein
HOSPIRA - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 52584-638-02 - 100 ug/mL