Fluoxetine HCl

Product NDC

49909-005

11-digit product format

499090005

Labeler code

49909

Product ID

49909-005_f0a88a56-7590-d699-a012-480627956b9c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Fluoxetine HCl

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Edgemont Pharmaceuticals, LLC

Application

NDA202133

Marketing category

NDA

Marketing start

2011-11-14

Marketing end

2020-02-29

Substance

FLUOXETINE HYDROCHLORIDE

Active strength

60 mg/1

Pharmacologic classes

Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record