Zolpidem Tartrate

Product NDC

43353-620

11-digit product format

433530620

Labeler code

43353

Product ID

43353-620_e3b4f606-6863-49a5-be7c-48d86b85bdaf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

zolpidem tartrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Aphena Pharma Solutions - Tennessee, LLC

Application

ANDA078616

Marketing category

ANDA

Marketing start

2008-11-21

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