"71288-505-03" National Drug Code (NDC)

Dexmedetomidine 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)
(Meitheal Pharmaceuticals Inc.)

NDC Code71288-505-03
Package Description25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)
Product NDC71288-505
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine
Non-Proprietary NameDexmedetomidine
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20190118
Marketing Category NameANDA
Application NumberANDA204843
ManufacturerMeitheal Pharmaceuticals 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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