rufinamide

Generic: rufinamide

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler bionpharma inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-223
Product ID 69452-223_3d338656-9665-cc13-e063-6294a90ab433
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211388
Listing Expiration 2026-12-31
Marketing Start 2018-12-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452223
Hyphenated Format 69452-223

Supplemental Identifiers

RxCUI
1092357
UPC
0369452223840
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 ANDA211388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69452-223-84) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

69452-223-84 1 BOTTLE in 1 CARTON (69452-223-84) / 460 mL in 1 BOTTLE

Ingredients (1)

rufinamide (40 mg/mL)

Linked Drug Pages (1)

Rufinamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d338656-9665-cc13-e063-6294a90ab433", "openfda": {"upc": ["0369452223840"], "unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["e2ba061a-49f0-4330-b0f0-00f2c3725625"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-223-84)  / 460 mL in 1 BOTTLE", "package_ndc": "69452-223-84", "marketing_start_date": "20201106"}], "brand_name": "Rufinamide", "product_id": "69452-223_3d338656-9665-cc13-e063-6294a90ab433", "dosage_form": "SUSPENSION", "product_ndc": "69452-223", "generic_name": "Rufinamide", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA211388", "marketing_category": "ANDA", "marketing_start_date": "20181219", "listing_expiration_date": "20261231"}