tizanidine
- Product NDC
- 0615-8469
- 11-digit product format
- 006158469
- Labeler code
- 0615
- Product ID
- 0615-8469_71f3b942-c268-4e2c-a338-1151bd805f86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- 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 | 313412, 313413 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8469-39 | tizanidine | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8469 | TIZANIDINE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 3 | Current NDC, 1 package rows | 20240806_c8278b4e-cca2-4880-8924-c8202ce084d6.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 |
|---|
| 0615-8469-39 | 00615846939 | 30 TABLET in 1 BLISTER PACK (0615-8469-39) | 30 tablet | 2023-05-10 | No | No | Current |