"53345-037-01" National Drug Code (NDC)

Dutasteride 1 BAG in 1 BOX (53345-037-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG
(Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.)

NDC Code53345-037-01
Package Description1 BAG in 1 BOX (53345-037-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG
Product NDC53345-037
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDutasteride
Non-Proprietary NameDutasteride
Dosage FormCAPSULE, LIQUID FILLED
UsageORAL
Start Marketing Date20180425
Marketing Category NameANDA
Application NumberANDA209909
ManufacturerHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Substance NameDUTASTERIDE
Strength.5
Strength Unitmg/1
Pharmacy Classes5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]

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