Zolpidem tartrate

Product NDC
68788-7903
11-digit product format
687887903
Labeler code
68788
Product ID
68788-7903_017da303-9b20-46ab-9a39-3894ec141c72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090107
Marketing category
ANDA
Marketing start
2021-05-14
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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
68788-7903-36878879030330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-3) 2021-05-140000-00-00NoNoCurrent
68788-7903-66878879030660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-6) 2021-05-140000-00-00NoNoCurrent
68788-7903-96878879030990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-9) 2021-05-140000-00-00NoNoCurrent