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 50090-7537
Product ID 50090-7537_183e1875-7234-42e5-bff7-6408e64f2dfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212308
Listing Expiration 2026-12-31
Marketing Start 2019-04-26

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907537
Hyphenated Format 50090-7537

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 ANDA212308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-7537-0)
source: ndc

Packages (1)

50090-7537-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-7537-0)

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": "183e1875-7234-42e5-bff7-6408e64f2dfe", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205285"], "spl_set_id": ["d6f5c510-9ec2-4e2d-b134-25c35bd23fee"], "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 (50090-7537-0)", "package_ndc": "50090-7537-0", "marketing_start_date": "20250409"}], "brand_name": "leflunomide", "product_id": "50090-7537_183e1875-7234-42e5-bff7-6408e64f2dfe", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "50090-7537", "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": "ANDA212308", "marketing_category": "ANDA", "marketing_start_date": "20190426", "listing_expiration_date": "20261231"}