NDC 0781-3494

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Dexmedetomidine Hydrochloride.

Product ID0781-3494_a7ea3417-a8d8-9d52-e053-2a95a90ae8bc
NDC0781-3494
Product TypeHuman Prescription Drug
Proprietary NameDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Generic NameDexmedetomidine Hydrochloride In 0.9% Sodium Chloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA209065
Labeler NameSandoz Inc.
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredient Strength4 ug/mL
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-3494-95

10 BOTTLE in 1 CARTON (0781-3494-95) > 50 mL in 1 BOTTLE
Marketing Start Date2020-06-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" or generic name "Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride"

NDCBrand NameGeneric Name
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
0781-3494DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
0781-3495DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
43066-555DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride
43066-557DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride
55150-296Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium Chloride
55150-297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium Chloride

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