"57664-596-50" National Drug Code (NDC)

Dexmedetomidine Hydrochloride 25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) > 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)
(Sun Pharmaceuticals Industries, Inc.)

NDC Code57664-596-50
Package Description25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) > 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)
Product NDC57664-596
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine Hydrochloride
Non-Proprietary NameDexmedetomidine Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20150408
Marketing Category NameANDA
Application NumberANDA202126
ManufacturerSun Pharmaceuticals Industries, 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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