Zolpidem Tartrate

Product NDC
60760-761
11-digit product format
607600761
Labeler code
60760
Product ID
60760-761_3bc88f83-18f8-0e8d-e063-6294a90a1eb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA077322
Marketing category
ANDA
Marketing start
2007-04-23
Substance
ZOLPIDEM TARTRATE
Active strength
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
60760-761-306076007613030 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-761-30) 2025-08-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zolpidem TartrateST. MARY'S MEDICAL PARK PHARMACY2025-08-07HUMAN PRESCRIPTION DRUG LABEL1