Prescription drug · ANDA
tizanidine NDC 0904-6418
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6418-61 | 00904641861 | 100 BLISTER PACK in 1 CARTON (0904-6418-61) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 1, 2014 |
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
- Generic name (nonproprietary)
- tizanidine
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076533
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 0904-6418_df0ee411-83ec-42cc-9cb5-4a809db29af1SPL ID df0ee411-83ec-42cc-9cb5-4a809db29af1SPL set ID d24e0cda-a22f-404f-b861-f85090cef099RxCUI 313413UNII 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
N400904641861followed by a unit qualifier and the quantityPackage 00904-6418-61. 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 treatment of spasticity. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076533
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 | Tizanidine hydrochloride 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-776 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Apotex Corp. | 60505-0251 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Apotex Corp. | 60505-0252 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Proficient Rx LP | 63187-145 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7287 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8741 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-455 |