rufinamide

Generic: rufinamide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rufinamide 400 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0426
Product ID 0054-0426_72348f03-413e-4d00-be89-00c719af669b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204988
Listing Expiration 2026-12-31
Marketing Start 2021-05-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540426
Hyphenated Format 0054-0426

Supplemental Identifiers

RxCUI
824295 824301
UPC
0300540425234 0300540426231
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 ANDA204988 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (0054-0426-23)
source: ndc

Packages (1)

0054-0426-23 120 TABLET, FILM COATED in 1 BOTTLE (0054-0426-23)

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": "72348f03-413e-4d00-be89-00c719af669b", "openfda": {"upc": ["0300540425234", "0300540426231"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824301"], "spl_set_id": ["56316809-6e73-4717-990b-fc84bf6bf433"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (0054-0426-23)", "package_ndc": "0054-0426-23", "marketing_start_date": "20210530"}], "brand_name": "Rufinamide", "product_id": "0054-0426_72348f03-413e-4d00-be89-00c719af669b", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0054-0426", "generic_name": "Rufinamide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "400 mg/1"}], "application_number": "ANDA204988", "marketing_category": "ANDA", "marketing_start_date": "20210530", "listing_expiration_date": "20261231"}