Tizanidine
- Product NDC
- 42291-809
- 11-digit product format
- 422910809
- Labeler code
- 42291
- Product ID
- 42291-809_d5c9e83d-60d6-fb9c-e053-2995a90a9731
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA076416
- Marketing category
- ANDA
- Marketing start
- 2015-07-28
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TIZANIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | B53E3NMY5C | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
| TIZANIDINE | ACTIVE MOIETY | 6AI06C00GW | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TIZANIDINE TABLET [AVKARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-809 | TIZANIDINE TABLET [AVKARE] | 7 | Legacy NDC | 20240111_150c131c-3dc5-8417-2dc0-d0d440fb1d34.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-809-15 | 42291080915 | 150 TABLET in 1 BOTTLE (42291-809-15) | 150 tablet | 2015-07-28 | 0000-00-00 | No | No | Current |