Prescription drug · NDA
Xarelto (Rivaroxaban) NDC 50458-580
Rivaroxaban 10 mg/1 · Tablet, Film coated · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-580-07 | 5045805800750458058007 | 7 TABLET, FILM COATED in 1 BOTTLE (50458-580-07)Marketed from Nov 1, 2017 · Sample package | |
| 50458-580-10 | 5045805801050458058010 | 10 BLISTER PACK in 1 CARTON (50458-580-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-580-01)Marketed from Jul 1, 2011 | |
| 50458-580-30 | 5045805803050458058030 | 30 TABLET, FILM COATED in 1 BOTTLE (50458-580-30)Marketed from Jul 1, 2011 | |
| 50458-580-90 | 5045805809050458058090 | 90 TABLET, FILM COATED in 1 BOTTLE (50458-580-90)Marketed from Nov 1, 2017 |
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)
- Xarelto
- Generic name (nonproprietary)
- rivaroxaban
- Active ingredients
- Rivaroxaban — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022406
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 50458-580_5294926b-7812-41da-a0e8-56f492198450SPL ID 5294926b-7812-41da-a0e8-56f492198450SPL set ID 10db92f9-2300-4a80-836b-673e1ae91610RxCUI 1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, 2059017, 2588062, 2588066UNII 9NDF7JZ4M3UPC 0350458575019, 0350458579307, 0350458580303, 0350458578300, 0350458577600
- Pharmacologic class
- Factor Xa Inhibitor
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
N450458058007followed by a unit qualifier and the quantityPackage 50458-0580-07. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (…
Excerpt only. Read the full label for complete information.
About NDC 50458-580
- What is NDC 50458-580?
- 50458-580 is the product NDC for Xarelto (rivaroxaban), Rivaroxaban 10 mg/1 tablet, film coated, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xarelto (Rivaroxaban).
- What is the active ingredient?
- Rivaroxaban.
- Who is the labeler?
- Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xarelto?
- 12 other product NDCs are listed under this name. See all Xarelto NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xarelto products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xareltorivaroxaban | Rivaroxaban 155 mg/1 | Granule, For suspensionOral | Janssen Pharmaceuticals, Inc. | 50458-575 | 50458-0575-01 |
| Xareltorivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-577 | 50458-0577-1050458-0577-1450458-0577-18+1 more |
| Xareltorivaroxaban | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-584 | 50458-0584-5150458-0584-52 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3639 | 50090-3639-00 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4468 | 50090-4468-00 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-579 | 50458-0579-0750458-0579-1050458-0579-30+2 more |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1423 | 55154-1423-08 |
| Xareltorivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-578 | 50458-0578-0750458-0578-1050458-0578-30+1 more |
| Xareltorivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1424 | 55154-1424-08 |
| Xareltorivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3625 | 50090-3625-0050090-3625-01 |
Other NDCs under NDA 022406
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 |
|---|---|---|---|---|
| Xareltorivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1424 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1423 |
| Xareltorivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-577 |
| Xareltorivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-578 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-579 |
| Xareltorivaroxaban | — | Kit | Janssen Pharmaceuticals, Inc. | 50458-584 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4468 |
| Xareltorivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4469 |
| Xareltorivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-690 |
| Xareltorivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3625 |
| Xareltorivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3639 |