Prescription drug · NDA
Arava (leflunomide) NDC 0088-2161
Leflunomide 20 mg/1 · Tablet, Film coated · Oral · sanofi-aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0088-2161-30 | 00088216130 | 1 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 19, 1998 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- sanofi-aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020905
- Marketing start
- Listing expires
- Identifiers
- Product ID 0088-2161_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
N400088216130followed by a unit qualifier and the quantityPackage 00088-2161-30. 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)
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.
Other NDCs under NDA 020905
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.