leflunomide

Generic: leflunomide

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-2503
Product ID 60505-2503_ebee26d4-bf2a-e0eb-b0f4-e1212d0bed03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077090
Listing Expiration 2026-12-31
Marketing Start 2005-09-13

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605052503
Hyphenated Format 60505-2503

Supplemental Identifiers

RxCUI
205284 205285
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 ANDA077090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (60505-2503-1)
  • 100 TABLET in 1 BOTTLE (60505-2503-2)
  • 1000 TABLET in 1 BOTTLE (60505-2503-3)
source: ndc

Packages (3)

60505-2503-1 30 TABLET in 1 BOTTLE (60505-2503-1) 60505-2503-2 100 TABLET in 1 BOTTLE (60505-2503-2) 60505-2503-3 1000 TABLET in 1 BOTTLE (60505-2503-3)

Ingredients (1)

leflunomide (20 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": "ebee26d4-bf2a-e0eb-b0f4-e1212d0bed03", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["753453c5-8a7a-878e-3ce7-1d1edce718a9"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (60505-2503-1)", "package_ndc": "60505-2503-1", "marketing_start_date": "20050913"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (60505-2503-2)", "package_ndc": "60505-2503-2", "marketing_start_date": "20050913"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (60505-2503-3)", "package_ndc": "60505-2503-3", "marketing_start_date": "20050913"}], "brand_name": "LEFLUNOMIDE", "product_id": "60505-2503_ebee26d4-bf2a-e0eb-b0f4-e1212d0bed03", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "60505-2503", "generic_name": "LEFLUNOMIDE", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEFLUNOMIDE", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA077090", "marketing_category": "ANDA", "marketing_start_date": "20050913", "listing_expiration_date": "20261231"}