leflunomide

Generic: leflunomide

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler burel pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

leflunomide 10 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-447
Product ID 35573-447_81914a50-0e77-480d-aec5-2889b31a66d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213497
Listing Expiration 2026-12-31
Marketing Start 2022-01-03

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573447
Hyphenated Format 35573-447

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 ANDA213497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30)
source: ndc

Packages (1)

35573-447-30 30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30)

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": "81914a50-0e77-480d-aec5-2889b31a66d3", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["fc044417-cd9a-42f6-8a3d-a14e7c2f81a2"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30)", "package_ndc": "35573-447-30", "marketing_start_date": "20220103"}], "brand_name": "Leflunomide", "product_id": "35573-447_81914a50-0e77-480d-aec5-2889b31a66d3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "35573-447", "generic_name": "leflunomide", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "10 mg/1"}], "application_number": "ANDA213497", "marketing_category": "ANDA", "marketing_start_date": "20220103", "listing_expiration_date": "20261231"}