Prescription drug · ANDA
Rivaroxaban NDC 76282-774
Rivaroxaban 2.5 mg/1 · Tablet, Film coated · Oral · Exelan pharmaceuticals,Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-774-18 | 7628207741876282077418 | 180 TABLET, FILM COATED in 1 BOTTLE (76282-774-18)Marketed from Aug 4, 2025 | |
| 76282-774-60 | 7628207746076282077460 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-774-60)Marketed from Aug 4, 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
- Exelan pharmaceuticals,IncNDC labeler code 76282
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218117
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-774_fcd1f593-213c-490f-b0d1-75b2d7817582SPL ID fcd1f593-213c-490f-b0d1-75b2d7817582SPL set ID c2f55475-2a98-43f3-9eac-93995904ebc5RxCUI 2059015UNII 9NDF7JZ4M3UPC 0376282774602
- 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
N476282077418followed by a unit qualifier and the quantityPackage 76282-0774-18. 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 is 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 R…
Excerpt only. Read the full label for complete information.
About NDC 76282-774
- What is NDC 76282-774?
- 76282-774 is the product NDC for Rivaroxaban, Rivaroxaban 2.5 mg/1 tablet, film coated, listed with the FDA by Exelan pharmaceuticals,Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rivaroxaban.
- What is the active ingredient?
- Rivaroxaban.
- Who is the labeler?
- Exelan pharmaceuticals,Inc, NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rivaroxaban?
- 32 other product NDCs are listed under this name. See all Rivaroxaban NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rivaroxaban products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-006 | 70756-0006-1270756-0006-6070756-0006-81+1 more |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | TabletOral | Micro Labs Limited | 42571-345 | 42571-0345-0542571-0345-3042571-0345-60 |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-890 | 72603-0890-0172603-0890-02 |
| rivaroxaban | Rivaroxaban 10 mg/1 | Tablet, Film coatedOral | Changzhou Pharmaceutical Factory | 55488-0540 | 55488-0540-01 |
| rivaroxaban | Rivaroxaban 15 mg/1 | Tablet, Film coatedOral | Changzhou Pharmaceutical Factory | 55488-0541 | 55488-0541-01 |
| rivaroxaban | Rivaroxaban 20 mg/1 | Tablet, Film coatedOral | Changzhou Pharmaceutical Factory | 55488-0542 | 55488-0542-01 |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals, Inc. | 72865-321 | 72865-0321-1872865-0321-60 |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-416 | 72205-0416-0272205-0416-0372205-0416-04+1 more |
| Rivaroxaban | Rivaroxaban 2.5 mg/1 | Tablet, CoatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4228 | 51672-4228-0451672-4228-09 |
| rivaroxaban | Rivaroxaban 2.5 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-405 | 71921-0405-0671921-0405-21 |
Other NDCs under ANDA 218117
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 | ScieGen pharmaceuticals,Inc | 50228-513 |