Prescription drug · ANDA
Rivaroxaban NDC 59651-849
Rivaroxaban 2.5 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-849-18 | 59651084918 | 180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18)Marketed from Apr 10, 2025 | |
| 59651-849-60 | 59651084960 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60)Marketed from Apr 10, 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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208544
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-849_41ba542b-b8da-4a6e-a39e-284fd6314627SPL ID 41ba542b-b8da-4a6e-a39e-284fd6314627SPL set ID bcb0e6e7-3006-4d82-8009-c5fddbbfc80dRxCUI 2059015UNII 9NDF7JZ4M3UPC 0359651849606
- 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
N459651084918followed by a unit qualifier and the quantityPackage 59651-0849-18. 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 tablets are a factor Xa inhibitor indicated: 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 (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.8 Reduction of …
Excerpt only. Read the full label for complete information.