Zolpidem tartrate

Product NDC
45865-956
11-digit product format
458650956
Labeler code
45865
Product ID
45865-956_9ade007c-bc12-e4b1-e053-2a95a90a8c54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA090107
Marketing category
ANDA
Marketing start
2011-10-31
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
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-956-304586509563030 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-956-30) 2018-12-120000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zolpidem tartratemedsource pharmaceuticals2019-12-29HUMAN PRESCRIPTION DRUG LABEL1