ZOLPIDEM TARTRATE

Product NDC
68788-7688
11-digit product format
687887688
Labeler code
68788
Product ID
68788-7688_e3538792-4e97-430d-90cc-93a5a36615e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078970
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 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
2022-12-31
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
68788-7688-26878876880228 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-2) 2020-04-010000-00-00NoNoCurrent
68788-7688-36878876880330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-3) 2020-04-010000-00-00NoNoCurrent
68788-7688-66878876880660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-6) 2020-04-010000-00-00NoNoCurrent
68788-7688-96878876880990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-9) 2020-04-010000-00-00NoNoCurrent