Tizanidine
- Product NDC
- 71335-2325
- 11-digit product format
- 713352325
- Labeler code
- 71335
- Product ID
- 71335-2325_3c16209f-1ef5-4738-b6c1-eb3afac50967
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076286
- Marketing category
- ANDA
- Marketing start
- 2002-07-03
- 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
openFDA Listing Details
- Product ID
- 71335-2325_3c16209f-1ef5-4738-b6c1-eb3afac50967
- SPL ID
- 3c16209f-1ef5-4738-b6c1-eb3afac50967
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Tizanidine
- Generic name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2002-07-03
- Marketing category
- ANDA
- Application number
- ANDA076286
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA]; Central alpha-2 Adrenergic Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| TIZANIDINE HYDROCHLORIDE | 4 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | B53E3NMY5C |
| Rxcui | 313413 |
| Spl Set Id | 492c99bd-2cd0-43be-bd70-800b739b7e83 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2325-0 | 112 TABLET in 1 BOTTLE (71335-2325-0) | 2024-01-08 | No |
| 71335-2325-1 | 30 TABLET in 1 BOTTLE (71335-2325-1) | 2024-01-08 | No |
| 71335-2325-2 | 60 TABLET in 1 BOTTLE (71335-2325-2) | 2024-01-08 | No |
| 71335-2325-3 | 90 TABLET in 1 BOTTLE (71335-2325-3) | 2024-01-08 | No |
| 71335-2325-4 | 120 TABLET in 1 BOTTLE (71335-2325-4) | 2024-01-08 | No |
| 71335-2325-5 | 20 TABLET in 1 BOTTLE (71335-2325-5) | 2024-01-08 | No |
| 71335-2325-6 | 45 TABLET in 1 BOTTLE (71335-2325-6) | 2024-01-08 | No |
| 71335-2325-7 | 140 TABLET in 1 BOTTLE (71335-2325-7) | 2024-01-08 | No |
| 71335-2325-8 | 84 TABLET in 1 BOTTLE (71335-2325-8) | 2024-01-08 | No |
| 71335-2325-9 | 28 TABLET in 1 BOTTLE (71335-2325-9) | 2024-01-08 | No |
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 |
|---|
| 71335-2325-0 | 71335232500 | 112 TABLET in 1 BOTTLE (71335-2325-0) | 112 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-1 | 71335232501 | 30 TABLET in 1 BOTTLE (71335-2325-1) | 30 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-2 | 71335232502 | 60 TABLET in 1 BOTTLE (71335-2325-2) | 60 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-3 | 71335232503 | 90 TABLET in 1 BOTTLE (71335-2325-3) | 90 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-4 | 71335232504 | 120 TABLET in 1 BOTTLE (71335-2325-4) | 120 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-5 | 71335232505 | 20 TABLET in 1 BOTTLE (71335-2325-5) | 20 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-6 | 71335232506 | 45 TABLET in 1 BOTTLE (71335-2325-6) | 45 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-7 | 71335232507 | 140 TABLET in 1 BOTTLE (71335-2325-7) | 140 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-8 | 71335232508 | 84 TABLET in 1 BOTTLE (71335-2325-8) | 84 tablet | 2024-01-08 | No | No | Historical |
| 71335-2325-9 | 71335232509 | 28 TABLET in 1 BOTTLE (71335-2325-9) | 28 tablet | 2024-01-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | Bryant Ranch Prepack | 2024-01-08 | HUMAN PRESCRIPTION DRUG LABEL | 101 |