Tizanidine
- Product NDC
- 71610-228
- 11-digit product format
- 716100228
- Labeler code
- 71610
- Product ID
- 71610-228_fb129009-348e-4512-a39f-e36fbf805c86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA091283
- Marketing category
- ANDA
- Marketing start
- 2013-04-01
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-228-30 | Tizanidine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 71610-228-53 | Tizanidine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 71610-228-60 | Tizanidine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-228 | TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20190214_ea242c7d-b101-4197-8e65-b2b079e3b2b6.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 |
|---|
| 71610-228-30 | 71610022830 | 30 TABLET in 1 BOTTLE, PLASTIC (71610-228-30) | 30 tablet | 2019-01-31 | 0000-00-00 | No | No | Current |
| 71610-228-53 | 71610022853 | 60 TABLET in 1 BOTTLE, PLASTIC (71610-228-53) | 60 tablet | 2019-01-31 | 0000-00-00 | No | No | Current |
| 71610-228-60 | 71610022860 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-228-60) | 90 tablet | 2019-01-31 | 0000-00-00 | No | No | Current |