Zolpidem Tartrate

Product NDC
47335-308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA204170
Marketing category
ANDA
Substance
ZOLPIDEM TARTRATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
47335-308-13500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-13) 2017-05-15NoHistorical
47335-308-88100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-88) 2017-05-15NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992Bryant Ranch Prepack2025-11-19HUMAN PRESCRIPTION DRUG LABEL101
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992Preferred Pharmaceuticals Inc.2025-10-08HUMAN PRESCRIPTION DRUG LABEL3
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992Preferred Pharmaceuticals Inc.2024-09-04HUMAN PRESCRIPTION DRUG LABEL2
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992Bryant Ranch Prepack2023-11-08HUMAN PRESCRIPTION DRUG LABEL5
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2023-10-18Human Prescription Drug Label13
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992A-S Medication Solutions2019-08-30Human Prescription Drug Label1
These highlights do not include all the information needed to use ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS. ZOLPIDEM TARTRATE extended-release tablets, for oral use, C-IV Initial U.S. Approval: 1992Aphena Pharma Solutions - Tennessee, LLC2019-03-02Human Prescription Drug Label1