Prescription drug · ANDA
Tizanidine Hydrochloride NDC 42291-811
Tizanidine hydrochloride 4 mg/1 · Capsule, Gelatin coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-811-15 | 42291081115 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15)Marketed from Jun 20, 2014 |
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)
- Tizanidine Hydrochloride
- Generic name (nonproprietary)
- tizanidine hydrochloride
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078868
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 42291-811_423ead2f-fbbc-830d-e063-6294a90aacfeSPL ID 423ead2f-fbbc-830d-e063-6294a90aacfeSPL set ID acc8f9f6-ceb6-0505-8f11-fd7e1f105af3RxCUI 485484, 485485, 485486UNII B53E3NMY5CUPC 0342291810150, 0342291812154, 0342291811157
- 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
N442291081115followed by a unit qualifier and the quantityPackage 42291-0811-15. 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)
Tizanidine is indicated for the treatment of spasticity in adults. Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine 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 42291-811
- What is NDC 42291-811?
- 42291-811 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 4 mg/1 capsule, gelatin coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tizanidine Hydrochloride.
- What is the active ingredient?
- Tizanidine hydrochloride.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tizanidine Hydrochloride?
- 55 other product NDCs are listed under this name. See all Tizanidine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tizanidine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tizanidine Hydrochloride | Tizanidine hydrochloride 8 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-089 | 73352-0089-60 |
| tizanidine hydrochloride | Tizanidine hydrochloride 8 mg/1 | CapsuleOral | Advagen Pharma Limited | 72888-161 | 72888-0161-15 |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0474 | 80425-0474-0180425-0474-0280425-0474-03+1 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8776 | 68788-8776-0168788-8776-0268788-8776-03+3 more |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0448 | 80425-0448-0180425-0448-0280425-0448-03 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8747 | 68788-8747-0168788-8747-0268788-8747-03+3 more |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8478 | 68788-8478-0168788-8478-0368788-8478-06+1 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2559 | 71335-2559-0171335-2559-0271335-2559-03+1 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-505 | 72789-0505-77 |
| tizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-506 | 72789-0506-77 |
Other NDCs under ANDA 078868
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 | Apotex Corp. | 60505-2648 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | Capsule, Gelatin coatedOral | Apotex Corp. | 60505-2649 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | Capsule, Gelatin coatedOral | Apotex Corp. | 60505-2650 |