Tizanidine
- Product NDC
- 68788-8802
- 11-digit product format
- 687888802
- Labeler code
- 68788
- Product ID
- 68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA091283
- Marketing category
- ANDA
- Marketing start
- 2025-01-02
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Tizanidine
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| TIZANIDINE HYDROCHLORIDE | 4 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | B53E3NMY5C |
| Rxcui | 313413 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| B53E3NMY5C | TIZANIDINE HYDROCHLORIDE | 64461-82-1 | TIZANIDINE HYDROCHLORIDE |
| 6AI06C00GW | TIZANIDINE | 51322-75-9 | Tizanidine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8802-1 | 68788880201 | 100 TABLET in 1 BOTTLE (68788-8802-1) | 100 tablet | 2025-01-02 | No | No | Historical |
| 68788-8802-2 | 68788880202 | 20 TABLET in 1 BOTTLE (68788-8802-2) | 20 tablet | 2025-01-02 | No | No | Historical |
| 68788-8802-3 | 68788880203 | 30 TABLET in 1 BOTTLE (68788-8802-3) | 30 tablet | 2025-01-02 | No | No | Historical |
| 68788-8802-6 | 68788880206 | 60 TABLET in 1 BOTTLE (68788-8802-6) | 60 tablet | 2025-01-02 | No | No | Historical |
| 68788-8802-8 | 68788880208 | 120 TABLET in 1 BOTTLE (68788-8802-8) | 120 tablet | 2025-01-02 | No | No | Historical |
| 68788-8802-9 | 68788880209 | 90 TABLET in 1 BOTTLE (68788-8802-9) | 90 tablet | 2025-01-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | Preferred Pharmaceuticals Inc. | 2025-01-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |