leflunomide

Generic: leflunomide

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5992
Product ID 50090-5992_81afc9f2-c82b-4373-80fb-f8c00942c79a
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 500905992
Hyphenated Format 50090-5992

Supplemental Identifiers

RxCUI
205285
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 ANDA213652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-5992-0)
source: ndc

Packages (1)

50090-5992-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-5992-0)

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": "81afc9f2-c82b-4373-80fb-f8c00942c79a", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205285"], "spl_set_id": ["0a4f8671-b632-4cc5-8dc9-6b863e62b467"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5992-0)", "package_ndc": "50090-5992-0", "marketing_start_date": "20220610"}], "brand_name": "Leflunomide", "product_id": "50090-5992_81afc9f2-c82b-4373-80fb-f8c00942c79a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "50090-5992", "generic_name": "Leflunomide", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA213652", "marketing_category": "ANDA", "marketing_start_date": "20210329", "listing_expiration_date": "20261231"}