tizanidine
- Product NDC
- 71610-776
- 11-digit product format
- 716100776
- Labeler code
- 71610
- Product ID
- 71610-776_2cee3817-e6f6-9db6-e063-6294a90a6ea1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076533
- Marketing category
- ANDA
- Marketing start
- 2004-01-16
- 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 |
|---|
| 71610-776-16 | 71610077616 | 6000 TABLET in 1 BOTTLE (71610-776-16) | 6000 tablet | 2024-01-25 | No | No | Historical |
| 71610-776-30 | 71610077630 | 30 TABLET in 1 BOTTLE (71610-776-30) | 30 tablet | 2024-01-22 | No | No | Historical |
| 71610-776-53 | 71610077653 | 60 TABLET in 1 BOTTLE (71610-776-53) | 60 tablet | 2024-01-25 | No | No | Historical |
| 71610-776-60 | 71610077660 | 90 TABLET in 1 BOTTLE (71610-776-60) | 90 tablet | 2024-01-25 | No | No | Historical |
| 71610-776-70 | 71610077670 | 120 TABLET in 1 BOTTLE (71610-776-70) | 120 tablet | 2025-01-24 | No | No | Historical |
| 71610-776-75 | 71610077675 | 7500 TABLET in 1 BOTTLE (71610-776-75) | 7500 tablet | 2024-04-01 | No | No | Historical |
| 71610-776-80 | 71610077680 | 180 TABLET in 1 BOTTLE (71610-776-80) | 180 tablet | 2025-01-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tizanidine | Aphena Pharma Solutions - Tennessee, LLC | 2025-01-29 | HUMAN PRESCRIPTION DRUG LABEL | 4 |