NDC 66794-230

Dexmedetomidine

Dexmedetomidine

Dexmedetomidine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Piramal Critical Care Inc. The primary component is Dexmedetomidine Hydrochloride.

Product ID66794-230_b93a71ed-0f9f-1ff9-e053-2995a90a789d
NDC66794-230
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine
Generic NameDexmedetomidine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA202126
Labeler NamePiramal Critical Care Inc
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredient Strength200 ug/2mL
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 66794-230-42

25 VIAL, GLASS in 1 CARTON (66794-230-42) > 2 mL in 1 VIAL, GLASS (66794-230-02)
Marketing Start Date2021-01-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Dexmedetomidine" or generic name "Dexmedetomidine"

NDCBrand NameGeneric Name
16729-239DexmedetomidineDexmedetomidine
16729-432DEXMEDETOMIDINEDEXMEDETOMIDINE
17478-055DexmedetomidineDexmedetomidine Hydrochloride
55150-209DexmedetomidineDexmedetomidine
57884-3091DEXMEDETOMIDINEDEXMEDETOMIDINE
66794-230DexmedetomidineDexmedetomidine
66794-233DexmedetomidineDexmedetomidine
66794-238DexmedetomidineDexmedetomidine
67457-251Dexmedetomidinedexmedetomidine
70860-605Dexmedetomidinedexmedetomidine
71288-505DEXMEDETOMIDINEDEXMEDETOMIDINE
71872-7150Dexmedetomidinedexmedetomidine
81092-1120IGALMIDEXMEDETOMIDINE
81092-1180IGALMIDEXMEDETOMIDINE

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