Zolpidem

Product NDC
71610-848
11-digit product format
716100848
Labeler code
71610
Product ID
71610-848_35bc5d7a-4115-4fd4-e063-6394a90a4f20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077214
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 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-848-107161008481010 TABLET in 1 BOTTLE (71610-848-10) 10 tablet2024-07-29NoNoHistorical
71610-848-147161008481414 TABLET in 1 BOTTLE (71610-848-14) 14 tablet2025-02-27NoNoHistorical
71610-848-157161008481515 TABLET in 1 BOTTLE (71610-848-15) 15 tablet2024-07-25NoNoHistorical
71610-848-207161008482020 TABLET in 1 BOTTLE (71610-848-20) 20 tablet2024-07-25NoNoHistorical
71610-848-217161008482121 TABLET in 1 BOTTLE (71610-848-21) 21 tablet2024-07-25NoNoHistorical
71610-848-257161008482525 TABLET in 1 BOTTLE (71610-848-25) 25 tablet2025-05-20NoNoHistorical
71610-848-287161008482828 TABLET in 1 BOTTLE (71610-848-28) 28 tablet2024-08-09NoNoHistorical
71610-848-307161008483030 TABLET in 1 BOTTLE (71610-848-30) 30 tablet2024-07-25NoNoHistorical
71610-848-457161008484545 TABLET in 1 BOTTLE (71610-848-45) 45 tablet2024-07-25NoNoHistorical
71610-848-537161008485360 TABLET in 1 BOTTLE (71610-848-53) 60 tablet2024-07-25NoNoHistorical
71610-848-607161008486090 TABLET in 1 BOTTLE (71610-848-60) 90 tablet2024-08-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZolpidemAphena Pharma Solutions - Tennessee, LLC2025-05-22HUMAN PRESCRIPTION DRUG LABEL6