Tizanidine
- Product NDC
- 10544-890
- 11-digit product format
- 105440890
- Labeler code
- 10544
- Product ID
- 10544-890_0edb4ada-614a-2f85-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA076286
- Marketing category
- ANDA
- Marketing start
- 2014-12-18
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a0ff02d8-b711-423c-b7d1-ada00d81c743 | Product name | 1 | 20250805 |
| 9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01 | Product name | 8 | 20250313 |
| b404127e-1c01-47bb-874e-db1e0b6bd9af | Product name | 4 | 20250313 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-890-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dd4d-f424-e053-dadaa90a57ce | Tizanidine Tablets USP |
| 10544-890-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dd4d-f424-e053-dadaa90a57ce | Tizanidine Tablets USP |
| 10544-890-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dd4d-f424-e053-dadaa90a57ce | Tizanidine Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-890-30 | Tizanidine | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 10544-890-60 | Tizanidine | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 10544-890-90 | Tizanidine | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-890-30 | EA - Each | 10544-890 | 4068bbf3-fead-46f3-b757-4512d007c642 | 1 | 2015-05-05 |
| 10544-890-60 | EA - Each | 10544-890 | bc848e6f-2972-4757-8482-0354e9226277 | 1 | 2015-05-05 |
| 10544-890-90 | EA - Each | 10544-890 | cc88f2d1-aa2b-48b8-ac06-4efbefb739aa | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | B53E3NMY5C | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| TIZANIDINE | ACTIVE MOIETY | 6AI06C00GW | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313413 | tiZANidine HCl 4 MG Oral Tablet | PSN | 0ed87a81-6ba1-2d8a-e054-00144ff8d46c | 3 |
| 313413 | tizanidine 4 MG Oral Tablet | SCD | 0ed87a81-6ba1-2d8a-e054-00144ff8d46c | 3 |
| 313413 | tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet | SY | 0ed87a81-6ba1-2d8a-e054-00144ff8d46c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-890-30 | 10544089030 | 30 in 1 BOTTLE | Historical |
| 10544-890-60 | 10544089060 | 60 in 1 BOTTLE | Historical |
| 10544-890-90 | 10544089090 | 90 in 1 BOTTLE | Historical |