tizanidine
- Product NDC
- 10544-576
- 11-digit product format
- 105440576
- Labeler code
- 10544
- Product ID
- 10544-576_9eb17a92-feec-42ce-b7ca-86367e164cc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA076533
- Marketing category
- ANDA
- Marketing start
- 2014-01-22
- Marketing end
- 0000-00-00
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-576-02 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-20 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-30 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-55 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-60 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-81 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-84 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
| 10544-576-90 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3e64-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use tizanidine safely and effectively. See full prescribing information for tizanidine. TIZANIDINE tablets, USP for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-576 | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 8 package rows | 20140801_4e2fd72f-4e76-411c-9ab8-441547141b34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-576-02 | 10544057602 | 120 in 1 BOTTLE | Historical |
| 10544-576-20 | 10544057620 | 20 in 1 BOTTLE | Historical |
| 10544-576-30 | 10544057630 | 30 in 1 BOTTLE | Historical |
| 10544-576-55 | 10544057655 | 150 in 1 BOTTLE | Historical |
| 10544-576-60 | 10544057660 | 60 in 1 BOTTLE | Historical |
| 10544-576-81 | 10544057681 | 180 in 1 BOTTLE | Historical |
| 10544-576-84 | 10544057684 | 84 in 1 BOTTLE | Historical |
| 10544-576-90 | 10544057690 | 90 in 1 BOTTLE | Historical |