Zolpidem Tartrate

Product NDC
50090-5095
11-digit product format
500905095
Labeler code
50090
Product ID
50090-5095_923ed88d-06b5-4c66-a0bd-3e3e63e1dc7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
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
50090-5095-05009050950090 TABLET, FILM COATED in 1 BOTTLE (50090-5095-0) 2020-07-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zolpidem TartrateA-S Medication Solutions2023-02-04Human Prescription Drug Label3