Zolpidem

Product NDC
72162-1983
11-digit product format
721621983
Labeler code
72162
Product ID
72162-1983_1e5b61b6-a5bd-4f09-9d34-905ce32f1899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
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
72162-1983-172162198301100 TABLET in 1 BOTTLE (72162-1983-1) 100 tablet2024-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZolpidemBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL101