Prescription drug · ANDA
Rivaroxaban NDC 14445-184
Rivaroxaban 20 mg/1 · Tablet, Film coated · Oral · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-184-00 | 14445018400 | 1000 TABLET, FILM COATED in 1 BOTTLE (14445-184-00)Marketed from Aug 11, 2025 | |
| 14445-184-10 | 14445018410 | 10 BLISTER PACK in 1 CARTON (14445-184-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-184-02)Marketed from Aug 11, 2025 | |
| 14445-184-30 | 14445018430 | 30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30)Marketed from Aug 11, 2025 | |
| 14445-184-90 | 14445018490 | 90 TABLET, FILM COATED in 1 BOTTLE (14445-184-90)Marketed from Aug 11, 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Indoco Remedies Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218445
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 14445-184_b57414a3-eca8-4cda-b7eb-7c060d52a6b6SPL ID b57414a3-eca8-4cda-b7eb-7c060d52a6b6SPL set ID 9fee7136-c8fd-4bea-ab15-7a0e7292396dRxCUI 1114198, 1232082, 1232086, 2059015UNII 9NDF7JZ4M3UPC 0314445184301, 0314445147603, 0314445148303, 0314445183304
- 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
N414445018400followed by a unit qualifier and the quantityPackage 14445-0184-00. 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 peripheral arter…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218445
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 | Indoco Remedies Limited | 14445-147 |
| Rivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-148 |
| Rivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-183 |
| rivaroxaban | Rivaroxaban 2.5 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-405 |