Prescription drug · ANDA
Leflunomide NDC 62135-793
Leflunomide 10 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-793-30 | 62135079330 | 30 TABLET in 1 BOTTLE (62135-793-30)Marketed from Oct 26, 2023 |
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)
- Leflunomide
- Generic name (nonproprietary)
- leflunomide
- Active ingredients
- Leflunomide — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077086
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-793_46268884-f963-f34a-e063-6294a90aa8d5SPL ID 46268884-f963-f34a-e063-6294a90aa8d5SPL set ID 006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1RxCUI 205284, 205285UNII G162GK9U4WUPC 0362135793302, 0362135794309
- 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
N462135079330followed by a unit qualifier and the quantityPackage 62135-0793-30. 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, USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62135-793
- What is NDC 62135-793?
- 62135-793 is the product NDC for Leflunomide, Leflunomide 10 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 10 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-447 | 35573-0447-30 |
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-448 | 35573-0448-30 |
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5992 | 50090-5992-00 |
| 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 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9728 | 63629-9728-01 |
| Leflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2256 | 71335-2256-0171335-2256-02 |
| Leflunomide | Leflunomide 10 mg/1 | TabletOral | AvPAK | 50268-477 | 50268-0477-15 |
| Leflunomide | Leflunomide 20 mg/1 | TabletOral | AvPAK | 50268-478 | 50268-0478-15 |
| Leflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3763 | 68071-3763-09 |
Other NDCs under ANDA 077086
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 10 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-043 |
| leflunomide | Leflunomide 20 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-044 |
| Leflunomide | Leflunomide 20 mg/1 | TabletOral | Chartwell RX, LLC | 62135-794 |
| leflunomide | Leflunomide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2832 |
| leflunomide | Leflunomide 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2874 |
| leflunomide | Leflunomide 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2409 |
| leflunomide | Leflunomide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2410 |