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.Initial U.S. Approval: 1987
Approved
Approval ID
20274ff0-f18c-4333-afab-e85ea236dea4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine
PRODUCT DETAILS
NDC Product Code75921-648
Application NumberANDA076001
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 16, 2012
Generic NameFluoxetine
INGREDIENTS (10)
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT