leflunomide

Generic: leflunomide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

leflunomide 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-348
Product ID 59651-348_e4a1828b-43bf-42dd-af71-5f9a3d49023c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213652
Listing Expiration 2026-12-31
Marketing Start 2021-03-29

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651348
Hyphenated Format 59651-348

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 ANDA213652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59651-348-30)
source: ndc

Packages (1)

59651-348-30 30 TABLET, FILM COATED in 1 BOTTLE (59651-348-30)

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": "e4a1828b-43bf-42dd-af71-5f9a3d49023c", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["c358276a-610e-46da-b81a-95c837af205d"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-348-30)", "package_ndc": "59651-348-30", "marketing_start_date": "20210329"}], "brand_name": "Leflunomide", "product_id": "59651-348_e4a1828b-43bf-42dd-af71-5f9a3d49023c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "59651-348", "generic_name": "Leflunomide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "10 mg/1"}], "application_number": "ANDA213652", "marketing_category": "ANDA", "marketing_start_date": "20210329", "listing_expiration_date": "20261231"}