leflunomide

Generic: leflunomide

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-794
Product ID 62135-794_46268884-f963-f34a-e063-6294a90aa8d5
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 62135794
Hyphenated Format 62135-794

Supplemental Identifiers

RxCUI
205284 205285
UPC
0362135793302 0362135794309
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 ANDA077086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-794-30)
source: ndc

Packages (1)

62135-794-30 30 TABLET in 1 BOTTLE (62135-794-30)

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": "46268884-f963-f34a-e063-6294a90aa8d5", "openfda": {"nui": ["N0000175713"], "upc": ["0362135793302", "0362135794309"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-794-30)", "package_ndc": "62135-794-30", "marketing_start_date": "20231026"}], "brand_name": "Leflunomide", "product_id": "62135-794_46268884-f963-f34a-e063-6294a90aa8d5", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "62135-794", "generic_name": "Leflunomide", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA077086", "marketing_category": "ANDA", "marketing_start_date": "20091029", "listing_expiration_date": "20261231"}