"53002-1016-0" National Drug Code (NDC)

Fluoxetine 100 CAPSULE in 1 BOTTLE (53002-1016-0)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1016-0
Package Description100 CAPSULE in 1 BOTTLE (53002-1016-0)
Product NDC53002-1016
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine
Non-Proprietary NameFluoxetine Hydrochloride
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20080131
Marketing Category NameANDA
Application NumberANDA078619
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength20
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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