"49483-703-01" National Drug Code (NDC)

Fluoxetine 100 CAPSULE in 1 BOTTLE (49483-703-01)
(TIME CAP LABORATORIES, INC.)

NDC Code49483-703-01
Package Description100 CAPSULE in 1 BOTTLE (49483-703-01)
Product NDC49483-703
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluoxetine
Non-Proprietary NameFluoxetine Hydrochloride
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20220212
Marketing Category NameANDA
Application NumberANDA075465
ManufacturerTIME CAP LABORATORIES, INC.
Substance NameFLUOXETINE HYDROCHLORIDE
Strength40
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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