leflunomide

Generic: leflunomide

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

Drug Facts

Product Profile

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

leflunomide 10 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3763
Product ID 68071-3763_2b5ca657-3fa5-8704-e063-6394a90a9f26
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 680713763
Hyphenated Format 68071-3763

Supplemental Identifiers

RxCUI
205284
UPC
0368071376395
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 ANDA211863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68071-3763-9) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

68071-3763-9 1 BOTTLE in 1 CARTON (68071-3763-9) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "2b5ca657-3fa5-8704-e063-6394a90a9f26", "openfda": {"nui": ["N0000175713"], "upc": ["0368071376395"], "unii": ["G162GK9U4W"], "rxcui": ["205284"], "spl_set_id": ["2b5c98d0-de59-85f6-e063-6394a90ab67a"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68071-3763-9)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68071-3763-9", "marketing_start_date": "20250110"}], "brand_name": "Leflunomide", "product_id": "68071-3763_2b5ca657-3fa5-8704-e063-6394a90a9f26", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "68071-3763", "generic_name": "Leflunomide", "labeler_name": "NuCare 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"}