Tizanidine Hydrochloride
- Product NDC
- 59651-315
- 11-digit product format
- 596510315
- Labeler code
- 59651
- Product ID
- 59651-315_c5462b0a-179b-449f-87e9-1ccfa18367b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213544
- Marketing category
- ANDA
- Marketing start
- 2020-03-24
- 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 Hydrochloride
- 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 | 485484, 485485, 485486 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-315-77 | Tizanidine Hydrochloride | 150 in 1 BOTTLE | CAPSULE | 150 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-315 | TIZANIDINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250123_19cf46b5-d8dc-44cb-83d6-bacea0870dbe.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 |
|---|
| 59651-315-77 | 59651031577 | 150 CAPSULE in 1 BOTTLE (59651-315-77) | 150 capsule | 2020-03-24 | 0000-00-00 | No | No | Current |