FDA.report

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) 20170515NoHistorical
47335-308-88100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-88) 20170515NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
8425be72-2bbe-4090-b00e-610f1a1646b1These 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
625fad5b-8817-4773-a2fc-20b662140e6eThese 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
625fad5b-8817-4773-a2fc-20b662140e6eThese 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
90201886-86a5-4c59-a4f1-98270d620731These 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
0c64bc71-2e7f-4b15-a8e1-acb8de04395fThese 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
4ac91321-0bf6-4f6b-99cf-472368f3e1c0These 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
ebd6c66b-b230-48d7-b38f-d610b6cb2b6cThese 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