leflunomide

Generic: leflunomide

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-477
Product ID 50268-477_47e6f1e5-f12c-c5d1-e063-6294a90a78b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077090
Listing Expiration 2027-12-31
Marketing Start 2020-09-17

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268477
Hyphenated Format 50268-477

Supplemental Identifiers

RxCUI
205284 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 ANDA077090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-477-15) / 1 TABLET in 1 BLISTER PACK (50268-477-11)
source: ndc

Packages (1)

50268-477-15 50 BLISTER PACK in 1 BOX (50268-477-15) / 1 TABLET in 1 BLISTER PACK (50268-477-11)

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": "47e6f1e5-f12c-c5d1-e063-6294a90a78b2", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["af836cd0-da42-772e-e053-2995a90ac103"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-477-15)  / 1 TABLET in 1 BLISTER PACK (50268-477-11)", "package_ndc": "50268-477-15", "marketing_start_date": "20200917"}], "brand_name": "LEFLUNOMIDE", "product_id": "50268-477_47e6f1e5-f12c-c5d1-e063-6294a90a78b2", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "50268-477", "generic_name": "LEFLUNOMIDE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEFLUNOMIDE", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "10 mg/1"}], "application_number": "ANDA077090", "marketing_category": "ANDA", "marketing_start_date": "20200917", "listing_expiration_date": "20271231"}