"68083-527-25" National Drug Code (NDC)

Dexmedetomidine 25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL
(Gland Pharma Limited)

NDC Code68083-527-25
Package Description25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL
Product NDC68083-527
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine
Non-Proprietary NameDexmedetomidine
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20210628
Marketing Category NameANDA
Application NumberANDA202126
ManufacturerGland Pharma Limited
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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