banzel

Generic: rufinamide

Labeler: eisai inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name banzel
Generic Name rufinamide
Labeler eisai inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rufinamide 400 mg/1

Manufacturer
Eisai Inc.

Identifiers & Regulatory

Product NDC 62856-583
Product ID 62856-583_0cc6f13a-0289-45f7-980e-3196d7489d75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021911
Listing Expiration 2026-12-31
Marketing Start 2008-11-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62856583
Hyphenated Format 62856-583

Supplemental Identifiers

RxCUI
824295 824299 824301 824303 1092357 1092360
UPC
0362856584463 0362856582520
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 banzel (source: ndc)
Generic Name rufinamide (source: ndc)
Application Number NDA021911 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14)
  • 120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52)
source: ndc

Packages (2)

62856-583-14 14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14) 62856-583-52 120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52)

Ingredients (1)

rufinamide (400 mg/1)

Linked Drug Pages (1)

Banzel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0cc6f13a-0289-45f7-980e-3196d7489d75", "openfda": {"upc": ["0362856584463", "0362856582520"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824299", "824301", "824303", "1092357", "1092360"], "spl_set_id": ["0a3fa925-1abd-458a-bd57-4ae780a1ef2d"], "manufacturer_name": ["Eisai Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14)", "package_ndc": "62856-583-14", "marketing_start_date": "20180808"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52)", "package_ndc": "62856-583-52", "marketing_start_date": "20081114"}], "brand_name": "Banzel", "product_id": "62856-583_0cc6f13a-0289-45f7-980e-3196d7489d75", "dosage_form": "TABLET, FILM COATED", "product_ndc": "62856-583", "generic_name": "rufinamide", "labeler_name": "Eisai Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Banzel", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "400 mg/1"}], "application_number": "NDA021911", "marketing_category": "NDA", "marketing_start_date": "20081114", "listing_expiration_date": "20261231"}