tizanidine
- Product NDC
- 71610-455
- 11-digit product format
- 716100455
- Labeler code
- 71610
- Product ID
- 71610-455_2c6a6719-33e4-44e8-bce6-30c10ae156a6
- 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
- 2 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 |
|---|
| 71610-455-09 | 71610045509 | 9000 TABLET in 1 BOTTLE (71610-455-09) | 9000 tablet | 2020-08-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tizanidine | Aphena Pharma Solutions - Tennessee, LLC | 2020-08-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |