leflunomide

Generic: leflunomide

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1158
Product ID 70710-1158_bd138e7f-33f1-44a4-886b-62f5bfbdfe09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212308
Listing Expiration 2026-12-31
Marketing Start 2019-04-26

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101158
Hyphenated Format 70710-1158

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 ANDA212308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70710-1158-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70710-1158-3)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70710-1158-5)
source: ndc

Packages (3)

70710-1158-1 100 TABLET, FILM COATED in 1 BOTTLE (70710-1158-1) 70710-1158-3 30 TABLET, FILM COATED in 1 BOTTLE (70710-1158-3) 70710-1158-5 500 TABLET, FILM COATED in 1 BOTTLE (70710-1158-5)

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": "bd138e7f-33f1-44a4-886b-62f5bfbdfe09", "openfda": {"nui": ["N0000175713"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["b9af9870-014f-4c4e-8738-bb04b30b3e85"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70710-1158-1)", "package_ndc": "70710-1158-1", "marketing_start_date": "20190426"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1158-3)", "package_ndc": "70710-1158-3", "marketing_start_date": "20190426"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70710-1158-5)", "package_ndc": "70710-1158-5", "marketing_start_date": "20190426"}], "brand_name": "leflunomide", "product_id": "70710-1158_bd138e7f-33f1-44a4-886b-62f5bfbdfe09", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "70710-1158", "generic_name": "leflunomide", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA212308", "marketing_category": "ANDA", "marketing_start_date": "20190426", "listing_expiration_date": "20261231"}