tizanidine hydrochloride
- Product NDC
- 0591-2790
- 11-digit product format
- 005912790
- Labeler code
- 0591
- Product ID
- 0591-2790_5c8f8c47-4f62-4954-8135-957c967dd7cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine hydrochloride
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021447
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-02-06
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 6 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- tizanidine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIZANIDINE HYDROCHLORIDE | 6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B53E3NMY5C |
| Rxcui | 485484, 485485, 485486 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2790-86 | tizanidine hydrochloride | 150 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 150 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TIZANIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | B53E3NMY5C | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| TIZANIDINE | ACTIVE MOIETY | 6AI06C00GW | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2790 | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240608_cb8b01b3-bcec-4762-9d67-0db018ef6b22.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2790-86 | 00591279086 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2790-86) | 2012-02-06 | 0000-00-00 | No | No | Current |