"0781-3494-95" National Drug Code (NDC)

Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 10 BOTTLE in 1 CARTON (0781-3494-95) / 50 mL in 1 BOTTLE
(Sandoz Inc.)

NDC Code0781-3494-95
Package Description10 BOTTLE in 1 CARTON (0781-3494-95) / 50 mL in 1 BOTTLE
Product NDC0781-3494
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine Hydrochloride In 0.9% Sodium Chloride
Non-Proprietary NameDexmedetomidine Hydrochloride In 0.9% Sodium Chloride
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20200612
Marketing Category NameANDA
Application NumberANDA209065
ManufacturerSandoz Inc.
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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