Prescription drug · ANDA
Rivaroxaban NDC 62332-683
Rivaroxaban 2.5 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-683-10 | 62332068310 | 100 BLISTER PACK in 1 CARTON (62332-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 14, 2025 | |
| 62332-683-45 | 62332068345 | 180 TABLET, FILM COATED in 1 BOTTLE (62332-683-45)Marketed from May 14, 2025 | |
| 62332-683-60 | 62332068360 | 60 TABLET, FILM COATED in 1 BOTTLE (62332-683-60)Marketed from May 14, 2025 | |
| 62332-683-91 | 62332068391 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-683-91)Marketed 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
- Active ingredients
- Rivaroxaban — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210301
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-683_30e909dc-eab4-4caf-831d-d46d4921b9ceSPL ID 30e909dc-eab4-4caf-831d-d46d4921b9ceSPL set ID e62f23c6-89f2-4179-95dc-5732401b3f93RxCUI 1114198, 1232082, 1232086, 1549682, 2059015UNII 9NDF7JZ4M3UPC 0362332347308, 0362332348305, 0362332683604, 0362332346301
- 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
N462332068310followed by a unit qualifier and the quantityPackage 62332-0683-10. 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 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 …
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 | — | Kit | Alembic Pharmaceuticals Limited | 46708-240 |
| 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 |