Zolpidem Tartrate

Product NDC

0378-5305

11-digit product format

003785305

Labeler code

0378

Product ID

0378-5305_3c15bfac-59f6-4e1b-a72b-e58b0108010d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zolpidem tartrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA076578

Marketing category

ANDA

Marketing start

2007-04-23

Marketing end

2019-12-31

Substance

ZOLPIDEM TARTRATE

Active strength

5 mg/1

Pharmacologic classes

gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]

DEA schedule

CIV

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record