Prescription drug · ANDA
leflunomide NDC 50090-7537
Leflunomide 20 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7537-0 | 50090753700 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7537-0)Marketed from Apr 9, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- leflunomide
- Generic name (nonproprietary)
- leflunomide
- Active ingredients
- Leflunomide — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212308
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-7537_183e1875-7234-42e5-bff7-6408e64f2dfeSPL ID 183e1875-7234-42e5-bff7-6408e64f2dfeSPL set ID d6f5c510-9ec2-4e2d-b134-25c35bd23feeRxCUI 205285UNII G162GK9U4W
- Pharmacologic class
- Antirheumatic Agent
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
N450090753700followed by a unit qualifier and the quantityPackage 50090-7537-00. 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)
Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
Excerpt only. Read the full label for complete information.
About NDC 50090-7537
- What is NDC 50090-7537?
- 50090-7537 is the product NDC for leflunomide, Leflunomide 20 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- leflunomide.
- What is the active ingredient?
- Leflunomide.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for leflunomide?
- 36 other product NDCs are listed under this name. See all leflunomide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other leflunomide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-448 | 35573-0448-30 |
| Leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-447 | 35573-0447-30 |
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2256 | 71335-2256-0171335-2256-02 |
| Leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9728 | 63629-9728-01 |
| Leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-348 | 59651-0348-30 |
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-349 | 59651-0349-30 |
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5992 | 50090-5992-00 |
| Leflunomide | Leflunomide 20 mg/1 | TabletOral | AvPAK | 50268-478 | 50268-0478-15 |
| Leflunomide | Leflunomide 10 mg/1 | TabletOral | AvPAK | 50268-477 | 50268-0477-15 |
| Leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3763 | 68071-3763-09 |
Other NDCs under ANDA 212308
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 |
|---|---|---|---|---|
| leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1492 |
| leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1491 |
| leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1158 |
| leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1157 |
| leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2403 |
| leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3764 |