Prescription drug · ANDA
Rivaroxaban NDC 43598-981
Rivaroxaban 2.5 mg/1 · Tablet · Oral · Dr.Reddy's Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-981-18 | 4359809811843598098118 | 180 TABLET in 1 BOTTLE (43598-981-18)Marketed from May 14, 2025 | |
| 43598-981-60 | 4359809816043598098160 | 60 TABLET in 1 BOTTLE (43598-981-60)Marketed from May 14, 2025 | |
| 43598-981-78 | 4359809817843598098178 | 10 BLISTER PACK in 1 CARTON (43598-981-78) / 10 TABLET in 1 BLISTER PACK (43598-981-79)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
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories, Inc.NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208534
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-981_eafdf7d8-5014-31c8-daa1-09fc017f5018SPL ID eafdf7d8-5014-31c8-daa1-09fc017f5018SPL set ID 122e6f78-067b-9065-adb2-ec7fec9f008eRxCUI 2059015UNII 9NDF7JZ4M3UPC 0343598981604
- 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
N443598098118followed by a unit qualifier and the quantityPackage 43598-0981-18. 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 tablet 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 …
Excerpt only. Read the full label for complete information.
About NDC 43598-981
- What is NDC 43598-981?
- 43598-981 is the product NDC for Rivaroxaban, Rivaroxaban 2.5 mg/1 tablet, listed with the FDA by Dr.Reddy's Laboratories, Inc.. It has 3 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?
- Dr.Reddy's Laboratories, Inc., NDC labeler code 43598. 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 |