"53002-1796-0" National Drug Code (NDC)

Fluoxetine Hydrochloride 100 TABLET in 1 BOTTLE (53002-1796-0)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1796-0
Package Description100 TABLET in 1 BOTTLE (53002-1796-0)
Product NDC53002-1796
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine Hydrochloride
Non-Proprietary NameFluoxetine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20190807
Marketing Category NameANDA
Application NumberANDA211653
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength10
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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