Fluoxetine Hydrochloride
These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Initial U.S. Approval: 1987
Approved
Approval ID
6bc0214b-b6f9-463d-a689-a93e59512b60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4537
Application NumberANDA075207
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2010
FDA Product Classification
INGREDIENTS (14)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
fluoxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4562
Application NumberANDA075207
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2010
FDA Product Classification
INGREDIENTS (15)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT