Prescription drug · ANDA
rivaroxaban NDC 71921-405
Rivaroxaban 2.5 mg/1 · Tablet · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71921-405-06 | 7192104050671921040506 | 60 TABLET in 1 BOTTLE (71921-405-06)Marketed from Aug 20, 2025 | |
| 71921-405-21 | 7192104052171921040521 | 180 TABLET in 1 BOTTLE (71921-405-21)Marketed from Aug 20, 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
- Route
- Oral
- Labeler
- Florida Pharmaceutical Products, LLCNDC labeler code 71921
- 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 71921-405_f0ef9361-f06d-4028-97af-183b545f4aeaSPL ID f0ef9361-f06d-4028-97af-183b545f4aeaSPL set ID f0ef9361-f06d-4028-97af-183b545f4aeaRxCUI 2059015UNII 9NDF7JZ4M3
- 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
N471921040506followed by a unit qualifier and the quantityPackage 71921-0405-06. 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 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, are 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 Risk of …
Excerpt only. Read the full label for complete information.
About NDC 71921-405
- What is NDC 71921-405?
- 71921-405 is the product NDC for rivaroxaban, Rivaroxaban 2.5 mg/1 tablet, listed with the FDA by Florida Pharmaceutical Products, LLC. 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?
- Florida Pharmaceutical Products, LLC, NDC labeler code 71921. 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 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-147 | 14445-0147-1014445-0147-1814445-0147-60 |
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 20 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-184 |