🇺🇸
United States · US · US:0088-2161_765327c7-cb5b-4637-84da-4fd9a024ad96
Arava
Orange BookUNIISPLATC L04AK01
Last synced from FDA National Drug Code directory (United States) on
Identification
Manufacturersanofi-aventis U.S. LLC
CountryUS (United States)
ATC codeL04AK01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100882161301 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
G162GK9U4W
LEFLUNOMIDE
RxCUI 27169
Orange Book
N020905
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G162GK9U4W",
"rxcui": "27169",
"inchikey": "VHOGYURTWQBHIL-UHFFFAOYSA-N",
"display_name": "LEFLUNOMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"320f63f2-fac3-4aee-aff8-85724e00ef52": {
"match": "brand_token",
"title": "ARAVA (LEFLUNOMIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]",
"spl_version": "27",
"published_date": "2025-06-09"
}
},
"productid": "0088-2161_765327c7-cb5b-4637-84da-4fd9a024ad96",
"productndc": "0088-2161",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020905",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 10, 1998"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Sep 10, 1998"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "003",
"approval_date": "Sep 10, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEFLUNOMIDE",
"proprietary_name": "Arava",
"active_ingred_unit": "mg/1",
"application_number": "NDA020905",
"marketing_category": "NDA",
"nonproprietary_name": "leflunomide",
"start_marketing_date": "19980910",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L04AK01.
Access this data programmatically
Query Arava and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.