Fluoxetine
These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Fluoxetine capsules USP for oral useInitial U.S. Approval: 1987
Approved
Approval ID
8609ed02-0b30-4c82-bab1-4d51d92ec224
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 1
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 Code67046-210
Application NumberANDA075452
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2009
FDA Product Classification
INGREDIENTS (10)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT