Sertraline Hydrochloride

Product NDC

0378-8011

11-digit product format

003788011

Labeler code

0378

Product ID

0378-8011_cf8e87b3-0c39-43f4-a1ef-630b54df5ac6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

sertraline

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc

Application

ANDA078626

Marketing category

ANDA

Marketing start

2013-05-29

Marketing end

2019-03-31

Substance

SERTRALINE HYDR

Active strength

25 mg/1

Pharmacologic classes

Serotonin Reupt

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record