Fluoxetine
These highlights do not include all the information needed to use Fluoxetine Capsules safely and effectively. See full prescribing information for Fluoxetine Capsules. Fluoxetine Capsules for oral use Initial U.S. Approval: 1987
Approved
Approval ID
59de2889-c3d3-4ebf-8826-13f30a3fa439
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2010
Manufacturers
FDA
McKesson Packaging Services Business Unit of McKesson Corporation
DUNS: 140529962
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine Capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-494
Application NumberANDA090223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine Capsules
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2010
FDA Product Classification
INGREDIENTS (8)
FLUOXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
Fluoxetine Capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63739-493
Application NumberANDA090223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine Capsules
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2010
FDA Product Classification
INGREDIENTS (8)
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT