Fluoxetine HCl
These highlights do not include all the information needed to use FLUOXETINE TABLETS safely and effectively. See full prescribing information for FLUOXETINE TABLETS. FLUOXETINE tablets, for oral useInitial U.S. Approval: 1987
Approved
Approval ID
02591302-fe4b-47e8-8dfc-bd1fd1b3764a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine HCl
PRODUCT DETAILS
NDC Product Code24979-255
Application NumberNDA202133
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 29, 2023
Generic NameFluoxetine HCl
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT