Tizanidine
- Product NDC
- 68788-7781
- 11-digit product format
- 687887781
- Labeler code
- 68788
- Product ID
- 68788-7781_c2ed0d31-f724-4410-85b9-eb03eb7ab9bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA076286
- Marketing category
- ANDA
- Marketing start
- 2020-09-01
- 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 table| Ingredient | Strength |
|---|
| TIZANIDINE HYDROCHLORIDE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B53E3NMY5C |
| Rxcui | 313413 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7781 | TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240821_32c3be66-5398-425c-ac65-e57ba819bb43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7781-1 | 68788778101 | 100 TABLET in 1 BOTTLE (68788-7781-1) | 100 tablet | 2020-09-01 | 0000-00-00 | No | No | Current |
| 68788-7781-2 | 68788778102 | 20 TABLET in 1 BOTTLE (68788-7781-2) | 20 tablet | 2020-09-01 | 0000-00-00 | No | No | Current |
| 68788-7781-3 | 68788778103 | 30 TABLET in 1 BOTTLE (68788-7781-3) | 30 tablet | 2020-09-01 | 0000-00-00 | No | No | Current |
| 68788-7781-6 | 68788778106 | 60 TABLET in 1 BOTTLE (68788-7781-6) | 60 tablet | 2020-09-01 | 0000-00-00 | No | No | Current |
| 68788-7781-8 | 68788778108 | 120 TABLET in 1 BOTTLE (68788-7781-8) | 120 tablet | 2020-09-01 | 0000-00-00 | No | No | Current |
| 68788-7781-9 | 68788778109 | 90 TABLET in 1 BOTTLE (68788-7781-9) | 90 tablet | 2020-09-01 | 0000-00-00 | No | No | Current |