Tizanidine
- Product NDC
- 71610-864
- 11-digit product format
- 716100864
- Labeler code
- 71610
- Product ID
- 71610-864_390c9dff-6c5c-7bfa-e063-6294a90ad843
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076416
- Marketing category
- ANDA
- Marketing start
- 2003-12-11
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| B53E3NMY5C | TIZANIDINE HYDROCHLORIDE | 64461-82-1 | TIZANIDINE HYDROCHLORIDE |
| 6AI06C00GW | TIZANIDINE | 51322-75-9 | Tizanidine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-864-16 | 71610086416 | 6000 TABLET in 1 BOTTLE (71610-864-16) | 6000 tablet | 2024-10-29 | No | No | Historical |
| 71610-864-30 | 71610086430 | 30 TABLET in 1 BOTTLE (71610-864-30) | 30 tablet | 2025-07-02 | No | No | Historical |
| 71610-864-53 | 71610086453 | 60 TABLET in 1 BOTTLE (71610-864-53) | 60 tablet | 2025-01-24 | No | No | Historical |
| 71610-864-60 | 71610086460 | 90 TABLET in 1 BOTTLE (71610-864-60) | 90 tablet | 2025-01-24 | No | No | Historical |
| 71610-864-80 | 71610086480 | 180 TABLET in 1 BOTTLE (71610-864-80) | 180 tablet | 2025-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-03 | HUMAN PRESCRIPTION DRUG LABEL | 4 |