Prescription drug · NDA
Zanaflex (Tizanidine hydrochloride) NDC 83107-001
Tizanidine hydrochloride 2 mg/1 · Capsule · Oral · Legacy Pharma USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-001-15 | 8310700011583107000115 | 150 CAPSULE in 1 BOTTLE (83107-001-15)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 — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Legacy Pharma USA, Inc.NDC labeler code 83107
- 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 83107-001_476ae6e6-0732-af36-e063-6394a90a7c02SPL ID 476ae6e6-0732-af36-e063-6394a90a7c02SPL set ID 60c27d35-7349-4fc6-86ad-70fffdbe3e08RxCUI 153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211UNII B53E3NMY5CUPC 0383107004158
- 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
N483107000115followed by a unit qualifier and the quantityPackage 83107-0001-15. 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 treatment of spasticity in adults. Zanaflex is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 83107-001
- What is NDC 83107-001?
- 83107-001 is the product NDC for Zanaflex (tizanidine hydrochloride), Tizanidine hydrochloride 2 mg/1 capsule, listed with the FDA by Legacy Pharma USA, 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?
- Legacy Pharma USA, Inc., NDC labeler code 83107. 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 4 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-604 | 70515-0604-15 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-606 | 70515-0606-15 |
| 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 4 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-604 |
| Zanaflextizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Covis Pharma US, Inc | 70515-606 |
| 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 |