Prescription drug · ANDA
tizanidine NDC 60505-0251
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0251-1 | 60505025101 | 100 TABLET in 1 BOTTLE (60505-0251-1)Marketed from Jan 16, 2004 | |
| 60505-0251-2 | 60505025102 | 1000 TABLET in 1 BOTTLE (60505-0251-2)Marketed from Jan 16, 2004 | |
| 60505-0251-3 | 60505025103 | 150 TABLET in 1 BOTTLE (60505-0251-3)Marketed from Jan 16, 2004 |
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
- Apotex Corp.
- 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 60505-0251_4bf9e490-aaca-0e56-d17d-9f513e09f552SPL ID 4bf9e490-aaca-0e56-d17d-9f513e09f552
- 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
N460505025101followed by a unit qualifier and the quantityPackage 60505-0251-01. 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
The FDA listing for this product does not reference a label (SPL) set.
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 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 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6418 |