"68083-238-20" National Drug Code (NDC)

Dexmedetomidine Hydrochloride 20 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL (68083-238-01)
(Gland Pharma Limited)

NDC Code68083-238-20
Package Description20 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL (68083-238-01)
Product NDC68083-238
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine Hydrochloride
Non-Proprietary NameDexmedetomidine Hydrochloride
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20200603
Marketing Category NameANDA
Application NumberANDA209307
ManufacturerGland Pharma Limited
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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