Tizanidine
- Product NDC
- 63629-2371
- 11-digit product format
- 636292371
- Labeler code
- 63629
- Product ID
- 63629-2371_2e2bd03e-7876-4c4e-8d08-c414d9a48dde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 63629-2371-1 | 63629237101 | 1000 TABLET in 1 BOTTLE (63629-2371-1) | 1000 tablet | 2021-02-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | Bryant Ranch Prepack | 2023-12-07 | HUMAN PRESCRIPTION DRUG LABEL | 103 |