"70518-4543-1" National Drug Code (NDC)

Fluoxetine 50 POUCH in 1 BOX (70518-4543-1) / 1 CAPSULE in 1 POUCH (70518-4543-2)
(REMEDYREPACK INC.)

NDC Code70518-4543-1
Package Description50 POUCH in 1 BOX (70518-4543-1) / 1 CAPSULE in 1 POUCH (70518-4543-2)
Product NDC70518-4543
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine
Non-Proprietary NameFluoxetine
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20260107
Marketing Category NameANDA
Application NumberANDA078619
ManufacturerREMEDYREPACK INC.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength20
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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