Fluoxetine Hydrochloride

Product NDC

0378-5410

11-digit product format

003785410

Labeler code

0378

Product ID

0378-5410_78bdcdf7-4ad8-4481-a5eb-52654bfda6dc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fluoxetine hydrochloride

Dosage form

CAPSULE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA078045

Marketing category

ANDA

Marketing start

2008-11-17

Marketing end

2019-10-31

Substance

FLUOXETINE HYDROCHLORIDE

Active strength

10 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