ZOLPIDEM TARTRATE
- Product NDC
- 43353-243
- 11-digit product format
- 433530243
- Labeler code
- 43353
- Product ID
- 43353-243_4ed996d1-66be-44cf-bbec-4a75fb121157
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077903
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 43353-243-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-14 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-15 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-28 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-45 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-53 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-59 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
| 43353-243-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc8f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM tartrate (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992. |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-243 | ZOLPIDEM TARTRATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 10 package rows | 20200101_c0543e05-3220-4a8a-abd9-6a73c42848c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-243-10 | 43353024310 | 10 TABLET in 1 BOTTLE (43353-243-10) | 10 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-14 | 43353024314 | 14 TABLET in 1 BOTTLE (43353-243-14) | 14 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-15 | 43353024315 | 15 TABLET in 1 BOTTLE (43353-243-15) | 15 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-20 | 43353024320 | 20 TABLET in 1 BOTTLE (43353-243-20) | 20 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-28 | 43353024328 | 28 TABLET in 1 BOTTLE (43353-243-28) | 28 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-30 | 43353024330 | 30 TABLET in 1 BOTTLE (43353-243-30) | 30 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-45 | 43353024345 | 45 TABLET in 1 BOTTLE (43353-243-45) | 45 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-53 | 43353024353 | 60 TABLET in 1 BOTTLE (43353-243-53) | 60 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-59 | 43353024359 | 22 TABLET in 1 BOTTLE (43353-243-59) | 22 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |
| 43353-243-60 | 43353024360 | 90 TABLET in 1 BOTTLE (43353-243-60) | 90 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |