NDC 66794-238

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 ID66794-238_cbf1eb7e-64e2-6b8c-e053-2a95a90af55f
NDC66794-238
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine
Generic NameDexmedetomidine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-24
Marketing CategoryANDA /
Application NumberANDA214794
Labeler NamePiramal Critical Care 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 66794-238-41

25 VIAL in 1 CARTON (66794-238-41) > 2 mL in 1 VIAL (66794-238-02)
Marketing Start Date2020-04-24
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.