"70518-4428-0" National Drug Code (NDC)

Fluoxetine 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4428-0)
(REMEDYREPACK INC.)

NDC Code70518-4428-0
Package Description30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4428-0)
Product NDC70518-4428
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine
Non-Proprietary NameFluoxetine
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20250806
Marketing Category NameANDA
Application NumberANDA213286
ManufacturerREMEDYREPACK INC.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength20
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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