"63323-671-50" National Drug Code (NDC)

Dexmedetomidine Hydrochloride 25 BOTTLE, GLASS in 1 CARTON (63323-671-50) / 50 mL in 1 BOTTLE, GLASS (63323-671-05)
(Fresenius Kabi USA, LLC)

NDC Code63323-671-50
Package Description25 BOTTLE, GLASS in 1 CARTON (63323-671-50) / 50 mL in 1 BOTTLE, GLASS (63323-671-05)
Product NDC63323-671
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine Hydrochloride
Non-Proprietary NameDexmedetomidine Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20190513
Marketing Category NameANDA
Application NumberANDA208129
ManufacturerFresenius Kabi USA, LLC
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Strength4
Strength Unitug/mL
Pharmacy ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]

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