Prescription drug · ANDA
rivaroxaban NDC 55488-0541
Rivaroxaban 15 mg/1 · Tablet, Film coated · Oral · Changzhou Pharmaceutical Factory
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55488-0541-1 | 55488054101 | 30 TABLET, FILM COATED in 1 BOTTLE (55488-0541-1)Marketed from Feb 1, 2026 |
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)
- rivaroxaban
- Generic name (nonproprietary)
- rivaroxaban
- Active ingredients
- Rivaroxaban — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216995
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 55488-0541_8b1205ed-1f1c-4e13-8076-aefada9213adSPL ID 8b1205ed-1f1c-4e13-8076-aefada9213adSPL set ID 9178947d-9d58-4c1a-b158-6030e17556afRxCUI 1114198, 1232082, 1232086UNII 9NDF7JZ4M3UPC 0355488054114, 0355488054015, 0355488054213
- 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
N455488054101followed by a unit qualifier and the quantityPackage 55488-0541-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Rivaroxaban 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 disea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216995
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 |
|---|---|---|---|---|
| rivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | Changzhou Pharmaceutical Factory | 55488-0540 |
| rivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Changzhou Pharmaceutical Factory | 55488-0542 |