ZOLPIDEM TARTRATE
- Product NDC
- 12634-944
- 11-digit product format
- 126340944
- Labeler code
- 12634
- Product ID
- 12634-944_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZOLPIDEM TARTRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- APOTHECA, INC
- Application
- ANDA077884
- Marketing category
- ANDA
- Marketing start
- 2007-09-25
- 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
- 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 |
|---|
| 12634-944-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-59 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-64 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-65 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-71 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-79 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-82 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-85 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-91 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
| 12634-944-95 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dbd0-f424-e053-dadaa90a57ce | ZOLPIDEM TARTRATE, TABLETS CIV |
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZOLPIDEM TARTRATE | ACTIVE INGREDIENT | WY6W63843K | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| ZOLPIDEM | ACTIVE MOIETY | 7K383OQI23 | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| POLYVINYL ALCOHOl | INACTIVE INGREDIENT | 532B59J990 | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-944 | ZOLPIDEM TARTRATE TABLET [APOTHECA, INC] | 1 | Legacy NDC, 13 package rows | 20131127_7638e2bd-04c5-4ad2-8635-fb460ab4d1c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-944-00 | 12634094400 | 10 in 1 BOTTLE | Historical |
| 12634-944-01 | 12634094401 | 100 in 1 BOTTLE | Historical |
| 12634-944-50 | 12634094450 | 50 in 1 BOTTLE | Historical |
| 12634-944-59 | 12634094459 | 30 in 1 BLISTER PACK | Historical |
| 12634-944-64 | 12634094464 | 4 in 1 BLISTER PACK | Historical |
| 12634-944-65 | 12634094465 | 5 in 1 BLISTER PACK | Historical |
| 12634-944-71 | 12634094471 | 30 in 1 BOTTLE | Historical |
| 12634-944-79 | 12634094479 | 25 in 1 BOTTLE | Historical |
| 12634-944-80 | 12634094480 | 20 in 1 BOTTLE | Historical |
| 12634-944-82 | 12634094482 | 12 in 1 BOTTLE | Historical |
| 12634-944-85 | 12634094485 | 15 in 1 BOTTLE | Historical |
| 12634-944-91 | 12634094491 | 1 in 1 BLISTER PACK | Historical |
| 12634-944-95 | 12634094495 | 5 in 1 BOTTLE | Historical |