Fluoxetine
These highlights do not include all the information needed to use FLUOXETINE TABLETS safely and effectively. See full prescribing information for FLUOXETINE TABLETS. FLUOXETINE tablets, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
11544dea-2f5e-1536-584a-5d1f37a99770
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Dr.Reddy's Laboratories Limited
DUNS: 650562841
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 Code55111-150
Application NumberANDA076006
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (10)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Fluoxetine hydrochlorideActive
Quantity: 10 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT