Fluoxetine
These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987
Approved
Approval ID
a1575590-4bdd-4f66-91fb-337e5f681747
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-053
Application NumberANDA078619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2010
FDA Product Classification
INGREDIENTS (10)
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Fluoxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-052
Application NumberANDA078619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2010
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT