leflunomide

Generic: leflunomide

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 10 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-043
Product ID 23155-043_bb1ee142-184a-4202-9513-e2036758fa6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077086
Listing Expiration 2026-12-31
Marketing Start 2009-10-29

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155043
Hyphenated Format 23155-043

Supplemental Identifiers

RxCUI
205284 205285
UPC
0323155043037 0323155044034
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 leflunomide (source: ndc)
Generic Name leflunomide (source: ndc)
Application Number ANDA077086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (23155-043-03)
  • 500 TABLET in 1 BOTTLE (23155-043-05)
source: ndc

Packages (2)

23155-043-03 30 TABLET in 1 BOTTLE (23155-043-03) 23155-043-05 500 TABLET in 1 BOTTLE (23155-043-05)

Ingredients (1)

leflunomide (10 mg/1)

Linked Drug Pages (1)

leflunomide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bb1ee142-184a-4202-9513-e2036758fa6e", "openfda": {"nui": ["N0000175713"], "upc": ["0323155043037", "0323155044034"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["40dd071a-d07f-452f-bf1a-2a23b9d22ca4"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (23155-043-03)", "package_ndc": "23155-043-03", "marketing_start_date": "20091029"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (23155-043-05)", "package_ndc": "23155-043-05", "marketing_start_date": "20091029"}], "brand_name": "leflunomide", "product_id": "23155-043_bb1ee142-184a-4202-9513-e2036758fa6e", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "23155-043", "generic_name": "leflunomide", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "10 mg/1"}], "application_number": "ANDA077086", "marketing_category": "ANDA", "marketing_start_date": "20091029", "listing_expiration_date": "20261231"}