rufinamide

Generic: rufinamide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rufinamide 400 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-617
Product ID 59651-617_96d61d77-4de0-4c57-997d-014010177a86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217230
Listing Expiration 2026-12-31
Marketing Start 2023-06-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651617
Hyphenated Format 59651-617

Supplemental Identifiers

RxCUI
824295 824301
UPC
0359651616086
UNII
WFW942PR79

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 rufinamide (source: ndc)
Generic Name rufinamide (source: ndc)
Application Number ANDA217230 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (59651-617-08)
source: ndc

Packages (1)

59651-617-08 120 TABLET, FILM COATED in 1 BOTTLE (59651-617-08)

Ingredients (1)

rufinamide (400 mg/1)

Linked Drug Pages (1)

Rufinamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "96d61d77-4de0-4c57-997d-014010177a86", "openfda": {"upc": ["0359651616086"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824301"], "spl_set_id": ["d9ffc833-d902-41cb-8e8e-6bbba8e65b9e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (59651-617-08)", "package_ndc": "59651-617-08", "marketing_start_date": "20230616"}], "brand_name": "Rufinamide", "product_id": "59651-617_96d61d77-4de0-4c57-997d-014010177a86", "dosage_form": "TABLET, FILM COATED", "product_ndc": "59651-617", "generic_name": "rufinamide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "400 mg/1"}], "application_number": "ANDA217230", "marketing_category": "ANDA", "marketing_start_date": "20230616", "listing_expiration_date": "20261231"}