Zolpidem Tartrate

Product NDC
72162-2441
11-digit product format
721622441
Labeler code
72162
Product ID
72162-2441_5648ce94-ab6e-40c5-a40e-fa90d79e3c89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204170
Marketing category
ANDA
Marketing start
2017-05-15
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 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 formatDescriptionMarketing startSampleExclude flagStatus
72162-2441-172162244101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-1) 2025-01-15NoNoHistorical
72162-2441-37216224410330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-3) 2025-01-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zolpidem TartrateBryant Ranch Prepack2025-11-19HUMAN PRESCRIPTION DRUG LABEL101