"71656-089-04" National Drug Code (NDC)

Fluoxetine 120 mL in 1 BOTTLE (71656-089-04)
(Saptalis Pharmaceuticals, LLC.)

NDC Code71656-089-04
Package Description120 mL in 1 BOTTLE (71656-089-04)
Product NDC71656-089
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine
Non-Proprietary NameFluoxetine
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20250620
Marketing Category NameANDA
Application NumberANDA075525
ManufacturerSaptalis Pharmaceuticals, LLC.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength20
Strength Unitmg/5mL
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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