ZOLPIDEM TARTRATE

Product NDC
63187-558
11-digit product format
631870558
Labeler code
63187
Product ID
63187-558_abcdf937-6cde-4adf-97fe-599ac82e20f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
5 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-558-05631870558055 TABLET in 1 BOTTLE (63187-558-05) 5 tablet2019-02-01NoNoHistorical
63187-558-156318705581515 TABLET in 1 BOTTLE (63187-558-15) 15 tablet2018-12-01NoNoHistorical
63187-558-306318705583030 TABLET in 1 BOTTLE (63187-558-30) 30 tablet2018-12-01NoNoHistorical
63187-558-606318705586060 TABLET in 1 BOTTLE (63187-558-60) 60 tablet2018-12-01NoNoHistorical
63187-558-906318705589090 TABLET in 1 BOTTLE (63187-558-90) 90 tablet2018-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZOLPIDEM TARTRATEProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL5