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 useInitial U.S. Approval: 1987
Approved
Approval ID
5ebf287e-fc95-4a2c-a496-62c7cf6cbf38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-188
Application NumberANDA075452
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (15)
FLUOXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: CNTM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT