Zolpidem Tartrate

Product NDC

0054-0086

11-digit product format

000540086

Labeler code

0054

Product ID

0054-0086_84e16e83-b683-4e03-908a-2732c8b59628

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zolpidem tartrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Roxane Laboratories, Inc

Application

ANDA077214

Marketing category

ANDA

Marketing start

2007-04-27

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record