Prescription drug · ANDA
Rivaroxaban NDC 46708-240
Kit · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-240-51 | 46708024051 | 1 KIT in 1 CARTON (46708-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 14, 2025 |
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)
- Rivaroxaban
- Generic name (nonproprietary)
- rivaroxaban
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210301
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-240_4b61dc52-0593-4ef0-8246-a82ff6972842SPL ID 4b61dc52-0593-4ef0-8246-a82ff6972842SPL set ID 5524f30f-789d-4f5c-8f7c-d03a475b6d34RxCUI 1114198, 1232082, 1232086, 1549682, 2059015UNII 9NDF7JZ4M3
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N446708024051followed by a unit qualifier and the quantityPackage 46708-0240-51. 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 tablet 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 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 peri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210301
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 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-683 |
| Rivaroxaban | — | Kit | Alembic Pharmaceuticals Inc. | 62332-240 |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-683 |
| Rivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-346 |
| Rivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-347 |
| Rivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-348 |
| Rivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-347 |
| Rivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-346 |
| Rivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-348 |