TIZANIDINE HYDROCHLORIDE
- Product NDC
- 21695-126
- 11-digit product format
- 216950126
- Labeler code
- 21695
- Product ID
- 21695-126_03fa46db-3676-4e0b-876d-5d226036b73e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TIZANIDINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors
- Application
- ANDA076347
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 2 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 |
|---|---|---|---|---|---|
| 21695-126-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4986-48b1-e053-8cdaa90a720a | TIZANIDINE HYDROCHLORIDE |
| 21695-126-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4986-48b1-e053-8cdaa90a720a | TIZANIDINE HYDROCHLORIDE |
| 21695-126-72 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4986-48b1-e053-8cdaa90a720a | TIZANIDINE HYDROCHLORIDE |
| 21695-126-78 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4986-48b1-e053-8cdaa90a720a | TIZANIDINE HYDROCHLORIDE |
| 21695-126-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4986-48b1-e053-8cdaa90a720a | TIZANIDINE HYDROCHLORIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-126-28 | TIZANIDINE HYDROCHLORIDE | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 21695-126-30 | TIZANIDINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-126-72 | TIZANIDINE HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 21695-126-78 | TIZANIDINE HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET | 180 | 1 | |
| 21695-126-90 | TIZANIDINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-126-28 | EA - Each | 21695-126 | 4a244d1c-c459-43c8-bbdf-c0318a89c873 | 1 | 2012-07-24 |
| 21695-126-30 | EA - Each | 21695-126 | c35d784f-8d33-4cc9-bebe-57431332dae7 | 1 | 2012-07-24 |
| 21695-126-72 | EA - Each | 21695-126 | 33a2ccdc-b950-4d94-bd80-dc6355816ec1 | 1 | 2012-07-24 |
| 21695-126-78 | EA - Each | 21695-126 | 853fe769-88f7-4371-91ae-825c024762f3 | 1 | 2012-07-24 |
| 21695-126-90 | EA - Each | 21695-126 | 209f66e0-99c3-4756-9ea1-9e1748b42226 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | B53E3NMY5C | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 | |
| TIZANIDINE | ACTIVE MOIETY | 6AI06C00GW | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313412 | tiZANidine HCl 2 MG Oral Tablet | PSN | 4f0d83de-0810-4255-8114-443f8fb915de | 1 |
| 313413 | tiZANidine HCl 4 MG Oral Tablet | PSN | 4f0d83de-0810-4255-8114-443f8fb915de | 1 |
| 313412 | tizanidine 2 MG Oral Tablet | SCD | 4f0d83de-0810-4255-8114-443f8fb915de | 1 |
| 313413 | tizanidine 4 MG Oral Tablet | SCD | 4f0d83de-0810-4255-8114-443f8fb915de | 1 |
| 313412 | tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet | SY | 4f0d83de-0810-4255-8114-443f8fb915de | 1 |
| 313413 | tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet | SY | 4f0d83de-0810-4255-8114-443f8fb915de | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-126-28 | 21695012628 | 28 in 1 BOTTLE | Historical |
| 21695-126-30 | 21695012630 | 30 in 1 BOTTLE | Historical |
| 21695-126-72 | 21695012672 | 120 in 1 BOTTLE | Historical |
| 21695-126-78 | 21695012678 | 180 in 1 BOTTLE | Historical |
| 21695-126-90 | 21695012690 | 90 in 1 BOTTLE | Historical |