leflunomide

Generic: leflunomide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leflunomide
Generic Name leflunomide
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leflunomide 20 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-437
Product ID 46708-437_aa5c1860-7668-433b-bc17-c6de2b772e0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091369
Listing Expiration 2026-12-31
Marketing Start 2016-12-01

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708437
Hyphenated Format 46708-437

Supplemental Identifiers

RxCUI
205284 205285
UPC
0346708436308 0346708437305
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 ANDA091369 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (46708-437-30)
  • 100 TABLET in 1 BOTTLE (46708-437-31)
  • 60 TABLET in 1 BOTTLE (46708-437-60)
  • 500 TABLET in 1 BOTTLE (46708-437-71)
source: ndc

Packages (4)

46708-437-30 30 TABLET in 1 BOTTLE (46708-437-30) 46708-437-31 100 TABLET in 1 BOTTLE (46708-437-31) 46708-437-60 60 TABLET in 1 BOTTLE (46708-437-60) 46708-437-71 500 TABLET in 1 BOTTLE (46708-437-71)

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": "aa5c1860-7668-433b-bc17-c6de2b772e0f", "openfda": {"nui": ["N0000175713"], "upc": ["0346708436308", "0346708437305"], "unii": ["G162GK9U4W"], "rxcui": ["205284", "205285"], "spl_set_id": ["f6a4107e-b393-45ed-8e5a-70af5bd53826"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-437-30)", "package_ndc": "46708-437-30", "marketing_start_date": "20161201"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-437-31)", "package_ndc": "46708-437-31", "marketing_start_date": "20161201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (46708-437-60)", "package_ndc": "46708-437-60", "marketing_start_date": "20161201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-437-71)", "package_ndc": "46708-437-71", "marketing_start_date": "20161201"}], "brand_name": "Leflunomide", "product_id": "46708-437_aa5c1860-7668-433b-bc17-c6de2b772e0f", "dosage_form": "TABLET", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "46708-437", "generic_name": "Leflunomide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leflunomide", "active_ingredients": [{"name": "LEFLUNOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA091369", "marketing_category": "ANDA", "marketing_start_date": "20161201", "listing_expiration_date": "20261231"}