Zolpidem

Product NDC
71205-691
11-digit product format
712050691
Labeler code
71205
Product ID
71205-691_f76eb9d8-ca7d-4479-bd16-52a57f623b02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-691-307120506913030 TABLET in 1 BOTTLE (71205-691-30) 30 tablet2022-08-30NoNoHistorical
71205-691-607120506916060 TABLET in 1 BOTTLE (71205-691-60) 60 tablet2022-08-30NoNoHistorical
71205-691-907120506919090 TABLET in 1 BOTTLE (71205-691-90) 90 tablet2022-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZolpidemProficient Rx LP2022-08-01HUMAN PRESCRIPTION DRUG LABEL1