Prescription drug · ANDA
Tizanidine NDC 84386-024
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84386-024-77 | 84386002477 | 150 TABLET in 1 BOTTLE (84386-024-77)Marketed from Sep 1, 2026 | |
| 84386-024-99 | 84386002499 | 1000 TABLET in 1 BOTTLE (84386-024-99)Marketed from Sep 1, 2026 |
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
- Generic name (nonproprietary)
- tizanidine
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076282
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 84386-024_7ce17c02-7f1f-4d52-8b6f-52e385e12239SPL ID 7ce17c02-7f1f-4d52-8b6f-52e385e12239SPL set ID 7ce17c02-7f1f-4d52-8b6f-52e385e12239RxCUI 313412, 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
N484386002477followed by a unit qualifier and the quantityPackage 84386-0024-77. 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 tablets are indicated for the treatment of spasticity in adults. Tizanidine tablets are 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 076282
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 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-023 |