leflunomide

Generic: leflunomide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2409
Product ID 72162-2409_8cc23541-0457-4fc2-8098-4cdf8f5a0d1a
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 721622409
Hyphenated Format 72162-2409

Supplemental Identifiers

RxCUI
205284
UNII
G162GK9U4W
NUI
N0000175713

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 (72162-2409-3)
source: ndc

Packages (1)

72162-2409-3 30 TABLET in 1 BOTTLE (72162-2409-3)

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": "8cc23541-0457-4fc2-8098-4cdf8f5a0d1a", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284"], "spl_set_id": ["e76d7767-744f-4e52-956d-e59f7a924826"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72162-2409-3)", "package_ndc": "72162-2409-3", "marketing_start_date": "20241030"}], "brand_name": "leflunomide", "product_id": "72162-2409_8cc23541-0457-4fc2-8098-4cdf8f5a0d1a", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "72162-2409", "generic_name": "leflunomide", "labeler_name": "Bryant Ranch Prepack", "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"}