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
f1a9e2fc-f75a-46a6-82f1-c11fa0b281a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2013
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66116-464
Application NumberANDA076001
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2013
FDA Product Classification
INGREDIENTS (11)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT