tizanidine
- Product NDC
- 68071-3719
- 11-digit product format
- 680713719
- Labeler code
- 68071
- Product ID
- 68071-3719_2bae2620-0abb-7e55-e063-6394a90ad47c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA208187
- Marketing category
- ANDA
- Marketing start
- 2021-03-04
- 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 |
|---|
| 68071-3719-3 | tizanidine | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 68071-3719-9 | tizanidine | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3719 | TIZANIDINE TABLET [NUCARE PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250116_26cffb1f-21a0-017f-e063-6394a90afb1a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3719-3 | 68071371903 | 30 TABLET in 1 BOTTLE (68071-3719-3) | 30 tablet | 2024-11-13 | No | No | Historical |
| 68071-3719-9 | 68071371909 | 90 TABLET in 1 BOTTLE (68071-3719-9) | 90 tablet | 2025-01-14 | No | No | Historical |