"68382-124-25" National Drug Code (NDC)

Dexmedetomidine Hydrochloride 25 VIAL in 1 CARTON (68382-124-25) / 2 mL in 1 VIAL (68382-124-01)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-124-25
Package Description25 VIAL in 1 CARTON (68382-124-25) / 2 mL in 1 VIAL (68382-124-01)
Product NDC68382-124
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine Hydrochloride
Non-Proprietary NameDexmedetomidine Hydrochloride
Dosage FormINJECTION, SOLUTION, CONCENTRATE
UsageINTRAVENOUS
Start Marketing Date20180614
Marketing Category NameANDA
Application NumberANDA206798
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Strength100
Strength Unitug/mL
Pharmacy ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]

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