leflunomide

Generic: leflunomide

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler kvk-tech, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-278
Product ID 10702-278_3843c448-c1bf-a403-e063-6394a90a3e77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212453
Listing Expiration 2026-12-31
Marketing Start 2020-07-23

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702278
Hyphenated Format 10702-278

Supplemental Identifiers

RxCUI
205284 205285
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 ANDA212453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (10702-278-03)
source: ndc

Packages (1)

10702-278-03 30 TABLET in 1 BOTTLE (10702-278-03)

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": "3843c448-c1bf-a403-e063-6394a90a3e77", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (10702-278-03)", "package_ndc": "10702-278-03", "marketing_start_date": "20200723"}], "brand_name": "Leflunomide", "product_id": "10702-278_3843c448-c1bf-a403-e063-6394a90a3e77", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "10702-278", "generic_name": "Leflunomide", "labeler_name": "KVK-Tech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA212453", "marketing_category": "ANDA", "marketing_start_date": "20200723", "listing_expiration_date": "20261231"}