NDC 71288-505

DEXMEDETOMIDINE

Dexmedetomidine

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

Product ID71288-505_1c7d8dae-f096-475a-be07-9ec38fe5c273
NDC71288-505
Product TypeHuman Prescription Drug
Proprietary NameDEXMEDETOMIDINE
Generic NameDexmedetomidine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA204843
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredient Strength100 ug/mL
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71288-505-03

25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) > 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)
Marketing Start Date2019-01-18
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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