"50228-638-10" National Drug Code (NDC)

Fluoxetine 1000 TABLET in 1 BOTTLE (50228-638-10)
(ScieGen Pharmaceuticals, Inc.)

NDC Code50228-638-10
Package Description1000 TABLET in 1 BOTTLE (50228-638-10)
Product NDC50228-638
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine
Non-Proprietary NameFluoxetine Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20250911
Marketing Category NameANDA
Application NumberANDA211282
ManufacturerScieGen Pharmaceuticals, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength60
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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