ZOLPIDEM TARTRATE
- Product NDC
- 33261-172
- 11-digit product format
- 332610172
- Labeler code
- 33261
- Product ID
- 33261-172_a1bad093-8e73-403e-a4b7-f7fede4451d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077903
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 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
- 2019-12-31
- 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 |
|---|
| 33261-172-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-42 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV Initial U.S. Approval: 1992 |
| 33261-172-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-03f4-f424-e053-dadaa90a57ce | 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 tablets, USP -CIV 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 |
|---|
| 33261-172 | ZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 10 package rows | 20121004_06a454bc-50d0-45de-87db-f3e3502e3bb0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-172-00 | 33261017200 | 10 in 1 BOTTLE | Historical |
| 33261-172-02 | 33261017202 | 120 in 1 BOTTLE | Historical |
| 33261-172-12 | 33261017212 | 12 in 1 BOTTLE | Historical |
| 33261-172-14 | 33261017214 | 14 in 1 BOTTLE | Historical |
| 33261-172-15 | 33261017215 | 15 in 1 BOTTLE | Historical |
| 33261-172-20 | 33261017220 | 20 in 1 BOTTLE | Historical |
| 33261-172-30 | 33261017230 | 30 in 1 BOTTLE | Historical |
| 33261-172-42 | 33261017242 | 42 in 1 BOTTLE | Historical |
| 33261-172-60 | 33261017260 | 60 in 1 BOTTLE | Historical |
| 33261-172-90 | 33261017290 | 90 in 1 BOTTLE | Historical |