Fluoxetine
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 use Initial U.S. Approval:1987
Approved
Approval ID
dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 916488547
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-473
Application NumberANDA206937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (8)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Fluoxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-443
Application NumberANDA206937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM