Ambien CR

Product NDC

63629-3141

11-digit product format

636293141

Labeler code

63629

Product ID

63629-3141_5fb4a750-ce07-07e3-f66a-46b027d5d03c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zolpidem tartrate

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

NDA021774

Marketing category

NDA

Marketing start

2009-06-30

Marketing end

0000-00-00

Substance

ZOLPIDEM TARTRATE

Active strength

13 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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record