rufinamide

Generic: rufinamide

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler novadoz pharmaceuticals llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-038
Product ID 72205-038_924ffdf9-ce5f-4989-9a43-78a03ba3eaed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214817
Listing Expiration 2026-12-31
Marketing Start 2025-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205038
Hyphenated Format 72205-038

Supplemental Identifiers

RxCUI
1092357
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 ANDA214817 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72205-038-77) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

72205-038-77 1 BOTTLE in 1 CARTON (72205-038-77) / 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": "924ffdf9-ce5f-4989-9a43-78a03ba3eaed", "openfda": {"unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["924ffdf9-ce5f-4989-9a43-78a03ba3eaed"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72205-038-77)  / 460 mL in 1 BOTTLE", "package_ndc": "72205-038-77", "marketing_start_date": "20250601"}], "brand_name": "Rufinamide", "product_id": "72205-038_924ffdf9-ce5f-4989-9a43-78a03ba3eaed", "dosage_form": "SUSPENSION", "product_ndc": "72205-038", "generic_name": "Rufinamide", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA214817", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}