Tizanidine
- Product NDC
- 76420-866
- 11-digit product format
- 764200866
- Labeler code
- 76420
- Product ID
- 76420-866_259ac6fd-2a83-04c0-e063-6394a90af566
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA076286
- Marketing category
- ANDA
- Marketing start
- 2021-06-15
- 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 |
|---|
| 76420-866-00 | 76420086600 | 1000 TABLET in 1 BOTTLE (76420-866-00) | 1000 tablet | 2024-10-29 | No | No | Historical |
| 76420-866-12 | 76420086612 | 120 TABLET in 1 BOTTLE (76420-866-12) | 120 tablet | 2024-10-29 | No | No | Historical |
| 76420-866-15 | 76420086615 | 150 TABLET in 1 BOTTLE (76420-866-15) | 150 tablet | 2024-10-29 | No | No | Historical |
| 76420-866-30 | 76420086630 | 30 TABLET in 1 BOTTLE (76420-866-30) | 30 tablet | 2024-10-29 | No | No | Historical |
| 76420-866-60 | 76420086660 | 60 TABLET in 1 BOTTLE (76420-866-60) | 60 tablet | 2024-10-29 | No | No | Historical |
| 76420-866-90 | 76420086690 | 90 TABLET in 1 BOTTLE (76420-866-90) | 90 tablet | 2024-10-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-10-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |