arava

Generic: leflunomide

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name arava
Generic Name leflunomide
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
sanofi-aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0088-2161
Product ID 0088-2161_765327c7-cb5b-4637-84da-4fd9a024ad96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020905
Listing Expiration 2026-12-31
Marketing Start 1998-09-10

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00882161
Hyphenated Format 0088-2161

Supplemental Identifiers

RxCUI
205284 205285 205286 213377 213379 213380
UNII
G162GK9U4W
NUI
N0000175713

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name arava (source: ndc)
Generic Name leflunomide (source: ndc)
Application Number NDA020905 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0088-2161-30 1 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

leflunomide (20 mg/1)

Linked Drug Pages (1)

Arava ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "765327c7-cb5b-4637-84da-4fd9a024ad96", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285", "205286", "213377", "213379", "213380"], "spl_set_id": ["320f63f2-fac3-4aee-aff8-85724e00ef52"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["sanofi-aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0088-2161-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0088-2161-30", "marketing_start_date": "19980919"}], "brand_name": "Arava", "product_id": "0088-2161_765327c7-cb5b-4637-84da-4fd9a024ad96", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "0088-2161", "generic_name": "leflunomide", "labeler_name": "sanofi-aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arava", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "NDA020905", "marketing_category": "NDA", "marketing_start_date": "19980910", "listing_expiration_date": "20261231"}