leflunomide

Generic: leflunomide

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

leflunomide 10 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-129
Product ID 70748-129_5d28a5cf-ca54-4fcc-a459-2be6ba1afb3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211863
Listing Expiration 2026-12-31
Marketing Start 2020-08-31

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748129
Hyphenated Format 70748-129

Supplemental Identifiers

RxCUI
205284 205285
UPC
0370748129067 0370748130063
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 ANDA211863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70748-129-06)
source: ndc

Packages (1)

70748-129-06 30 TABLET, FILM COATED in 1 BOTTLE (70748-129-06)

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": "5d28a5cf-ca54-4fcc-a459-2be6ba1afb3e", "openfda": {"nui": ["N0000175713"], "upc": ["0370748129067", "0370748130063"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["5d48fded-b43b-461a-8488-ca1da5c41a03"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70748-129-06)", "package_ndc": "70748-129-06", "marketing_start_date": "20200831"}], "brand_name": "Leflunomide", "product_id": "70748-129_5d28a5cf-ca54-4fcc-a459-2be6ba1afb3e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "70748-129", "generic_name": "Leflunomide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "10 mg/1"}], "application_number": "ANDA211863", "marketing_category": "ANDA", "marketing_start_date": "20200831", "listing_expiration_date": "20261231"}