tizanidine
- Product NDC
- 0615-8469
- 11-digit product format
- 006158469
- Labeler code
- 0615
- Product ID
- 0615-8469_71f3b942-c268-4e2c-a338-1151bd805f86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA208187
- Marketing category
- ANDA
- Marketing start
- 2021-03-04
- 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 |
|---|
| 0615-8469-39 | 00615846939 | 30 TABLET in 1 BLISTER PACK (0615-8469-39) | 30 tablet | 2023-05-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tizanidine | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-08-05 | HUMAN PRESCRIPTION DRUG LABEL | 3 |