Prescription drug · NDA AUTHORIZED GENERIC
tizanidine hydrochloride NDC 0591-2790
Tizanidine hydrochloride 6 mg/1 · Capsule, Gelatin coated · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-2790-86 | 00591279086 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2790-86)Marketed from Feb 6, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- tizanidine hydrochloride
- Generic name (nonproprietary)
- tizanidine hydrochloride
- Active ingredients
- Tizanidine hydrochloride — 6 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021447
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 0591-2790_5c8f8c47-4f62-4954-8135-957c967dd7cbSPL ID 5c8f8c47-4f62-4954-8135-957c967dd7cbSPL set ID cb8b01b3-bcec-4762-9d67-0db018ef6b22RxCUI 485484, 485485, 485486UNII B53E3NMY5C
- Pharmacologic class
- Central alpha-2 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400591279086followed by a unit qualifier and the quantityPackage 00591-2790-86. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Tizanidine hydrochloride capsules are indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )] . Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021447
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| tizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | Capsule, Gelatin coatedOral | Actavis Pharma, Inc. | 0591-2788 |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | Capsule, Gelatin coatedOral | Actavis Pharma, Inc. | 0591-2789 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-002 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-001 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-003 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-606 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-602 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-604 |