ZOLPIDEM TARTRATE

Product NDC
68071-5093
11-digit product format
680715093
Labeler code
68071
Product ID
68071-5093_25182218-4083-8821-e063-6394a90ab4ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-5093-16807150930110 TABLET in 1 BOTTLE (68071-5093-1) 10 tablet2024-09-03NoNoHistorical
68071-5093-36807150930330 TABLET in 1 BOTTLE (68071-5093-3) 30 tablet2019-10-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-10-22HUMAN PRESCRIPTION DRUG LABEL5