Zolpidem Tartrate

Product NDC

50436-0116

11-digit product format

504360116

Labeler code

50436

Product ID

50436-0116_b0a2a7ca-8b8a-4a25-ac78-92f24db5091f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Zolpidem Tartrate

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Unit Dose Services

Application

ANDA078148

Marketing category

ANDA

Marketing start

2011-12-06

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record