Tizanidine
- Product NDC
- 72789-327
- 11-digit product format
- 727890327
- Labeler code
- 72789
- Product ID
- 72789-327_40bb3624-175c-7967-e063-6394a90af2dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 |
|---|
| 72789-327-20 | 72789032720 | 20 TABLET in 1 BOTTLE, PLASTIC (72789-327-20) | 20 tablet | 2023-06-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | PD-Rx Pharmaceuticals, Inc. | 2025-10-09 | HUMAN PRESCRIPTION DRUG LABEL | 12 |
| Tizanidine | PD-Rx Pharmaceuticals, Inc. | 2024-10-09 | HUMAN PRESCRIPTION DRUG LABEL | 11 |