Prescription drug · ANDA
tizanidine NDC 50090-7716
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7716-0 | 50090771600 | 30 TABLET in 1 BOTTLE (50090-7716-0)Marketed from Oct 15, 2025 | |
| 50090-7716-1 | 50090771601 | 60 TABLET in 1 BOTTLE (50090-7716-1)Marketed from Oct 15, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218920
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 50090-7716_9edb8ad4-7e86-4eb9-b5b9-466b466c3fe7SPL ID 9edb8ad4-7e86-4eb9-b5b9-466b466c3fe7SPL set ID 52830423-0430-410e-93af-169dc11b3565RxCUI 313412UNII 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
N450090771600followed by a unit qualifier and the quantityPackage 50090-7716-00. 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 218920
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 | Preferred Pharmaceuticals Inc. | 68788-4159 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-658 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-659 |