ZOLPIDEM TARTRATE

Product NDC
52959-880
11-digit product format
529590880
Labeler code
52959
Product ID
52959-880_67208dcd-25ba-45c9-9e5e-b71747ec6493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WY6W63843KZOLPIDEM TARTRATE99294-93-6ZOLPIDEM TARTRATE

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZOLPIDEM TARTRATEH.J. Harkins Company, Inc. | Torrent Pharmaceuticals Limited2011-08-18HUMAN PRESCRIPTION DRUG LABEL1