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
8953d343-d137-4ca5-a73f-3ceff1505b55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FLUOXETINE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code16590-100
Application NumberANDA075245
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 19, 2010
Generic NameFLUOXETINE HYDROCHLORIDE
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT