Zolpidem Tartrate

Product NDC
63187-682
11-digit product format
631870682
Labeler code
63187
Product ID
63187-682_1d5b9b11-cb94-486d-9780-aca61a75c076
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076410
Marketing category
ANDA
Marketing start
2007-04-23
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
63187-682-156318706821515 TABLET, FILM COATED in 1 BOTTLE (63187-682-15) 2016-04-01NoNoHistorical
63187-682-306318706823030 TABLET, FILM COATED in 1 BOTTLE (63187-682-30) 2016-04-01NoNoHistorical
63187-682-606318706826060 TABLET, FILM COATED in 1 BOTTLE (63187-682-60) 2016-04-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zolpidem TartrateProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3