Prescription drug · NDA
Zanaflex (Tizanidine hydrochloride) NDC 70515-604
Tizanidine hydrochloride 4 mg/1 · Capsule · Oral · Covis Pharma US, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70515-604-15 | 7051506041570515060415 | 150 CAPSULE in 1 BOTTLE (70515-604-15)Marketed from Aug 1, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Zanaflex
- Generic name (nonproprietary)
- tizanidine hydrochloride
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Covis Pharma US, IncNDC labeler code 70515
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021447
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 70515-604_3468e009-cfd1-f217-e063-6294a90a1429SPL ID 3468e009-cfd1-f217-e063-6294a90a1429SPL set ID 043d9e51-bfa2-4add-9058-5ece332f7e99RxCUI 153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211UNII B53E3NMY5CUPC 0370515602151, 0370515604155, 0370515594159, 0370515606159
- 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
N470515060415followed by a unit qualifier and the quantityPackage 70515-0604-15. 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)
Zanaflex is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Zanaflex should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )] . Zanaflex is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Zanaflex 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.
About NDC 70515-604
- What is NDC 70515-604?
- 70515-604 is the product NDC for Zanaflex (tizanidine hydrochloride), Tizanidine hydrochloride 4 mg/1 capsule, listed with the FDA by Covis Pharma US, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zanaflex (Tizanidine hydrochloride).
- What is the active ingredient?
- Tizanidine hydrochloride.
- Who is the labeler?
- Covis Pharma US, Inc, NDC labeler code 70515. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zanaflex?
- 8 other product NDCs are listed under this name. See all Zanaflex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zanaflex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 8 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-090 | 73352-0090-60 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | TabletOral | Covis Pharma US, Inc | 70515-594 | 70515-0594-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-602 | 70515-0602-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-606 | 70515-0606-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-001 | 83107-0001-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-002 | 83107-0002-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-003 | 83107-0003-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | TabletOral | Legacy Pharma USA, Inc. | 83107-004 | 83107-0004-15 |
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 |
| tizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | Capsule, Gelatin coatedOral | Actavis Pharma, Inc. | 0591-2790 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-602 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-606 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-001 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-002 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Legacy Pharma USA, Inc. | 83107-003 |