Prescription drug · NDA
Arava (Leflunomide) NDC 0088-2162
Leflunomide 100 mg/1 · Tablet, Film coated · Oral · sanofi-aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0088-2162-33 | 00088216233 | 1 BLISTER PACK in 1 CARTON (0088-2162-33) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 19, 1998 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Arava
- Generic name (nonproprietary)
- leflunomide
- Active ingredients
- Leflunomide — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- sanofi-aventis U.S. LLCNDC labeler code 0088
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020905
- Marketing start
- Listing expires
- Identifiers
- Product ID 0088-2162_765327c7-cb5b-4637-84da-4fd9a024ad96SPL ID 765327c7-cb5b-4637-84da-4fd9a024ad96SPL set ID 320f63f2-fac3-4aee-aff8-85724e00ef52RxCUI 205284, 205285, 205286, 213377, 213379, 213380UNII 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
N400088216233followed by a unit qualifier and the quantityPackage 00088-2162-33. 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)
ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is 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 0088-2162
- What is NDC 0088-2162?
- 0088-2162 is the product NDC for Arava (leflunomide), Leflunomide 100 mg/1 tablet, film coated, listed with the FDA by sanofi-aventis U.S. LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arava (Leflunomide).
- What is the active ingredient?
- Leflunomide.
- Who is the labeler?
- sanofi-aventis U.S. LLC, NDC labeler code 0088. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arava?
- 2 other product NDCs are listed under this name. See all Arava NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arava products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aravaleflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | sanofi-aventis U.S. LLC | 0088-2160 | 00088-2160-30 |
| Aravaleflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | sanofi-aventis U.S. LLC | 0088-2161 | 00088-2161-30 |
Other NDCs under NDA 020905
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 |
|---|---|---|---|---|
| Aravaleflunomide | Leflunomide 10 mg/1 | Tablet, Film coatedOral | sanofi-aventis U.S. LLC | 0088-2160 |
| Aravaleflunomide | Leflunomide 20 mg/1 | Tablet, Film coatedOral | sanofi-aventis U.S. LLC | 0088-2161 |