Ambien

Product NDC

49999-763

11-digit product format

499990763

Labeler code

49999

Product ID

49999-763_b14add9a-30ab-4cf1-b411-4f46d4ea09e7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zolpidem tartrate

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Application

NDA021774

Marketing category

NDA

Marketing start

2011-12-13

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