"70518-3904-0" National Drug Code (NDC)

Fluoxetine Hydrochloride 10 CUP, UNIT-DOSE in 1 BOX (70518-3904-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3904-1)
(REMEDYREPACK INC.)

NDC Code70518-3904-0
Package Description10 CUP, UNIT-DOSE in 1 BOX (70518-3904-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3904-1)
Product NDC70518-3904
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine Hydrochloride
Non-Proprietary NameFluoxetine Hydrochloride
Dosage FormFOR SOLUTION
UsageORAL
Start Marketing Date20231101
Marketing Category NameANDA
Application NumberANDA216953
ManufacturerREMEDYREPACK INC.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength20
Strength Unitmg/5mL
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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