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"53150-386-01" National Drug Code (NDC)

Idarubicin Hydrochloride 1 VIAL, SINGLE-DOSE in 1 CARTON (53150-386-01) > 10 mL in 1 VIAL, SINGLE-DOSE
(Amneal-Agila, LLC)

NDC Code53150-386-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (53150-386-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC53150-386
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIdarubicin Hydrochloride
Non-Proprietary NameIdarubicin Hydrochloride
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20130430
Marketing Category NameANDA
Application NumberANDA200144
ManufacturerAmneal-Agila, LLC
Substance NameIDARUBICIN HYDROCHLORIDE
Strength10
Strength Unitmg/10mL
Pharmacy ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]

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