ZOLPIDEM TARTRATE

Product NDC
55700-357
11-digit product format
557000357
Labeler code
55700
Product ID
55700-357_441aafa7-9b54-4c40-8339-afb197dab6e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
2027-10-31
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WY6W63843KZOLPIDEM TARTRATE99294-93-6ZOLPIDEM TARTRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-357-305570003573030 TABLET in 1 BOTTLE (55700-357-30) 30 tablet2016-01-132027-10-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLC2024-12-17HUMAN PRESCRIPTION DRUG LABEL12