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 SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-563
Product ID 59651-563_855369b6-9f5b-4951-9115-dbb9a74ac53b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216549
Listing Expiration 2026-12-31
Marketing Start 2022-10-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651563
Hyphenated Format 59651-563

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 ANDA216549 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-563-60 1 BOTTLE in 1 CARTON (59651-563-60) / 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": "855369b6-9f5b-4951-9115-dbb9a74ac53b", "openfda": {"unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["444544f0-7622-4eef-b218-f241bd50d4af"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-563-60)  / 460 mL in 1 BOTTLE", "package_ndc": "59651-563-60", "marketing_start_date": "20221026"}], "brand_name": "RUFINAMIDE", "product_id": "59651-563_855369b6-9f5b-4951-9115-dbb9a74ac53b", "dosage_form": "SUSPENSION", "product_ndc": "59651-563", "generic_name": "RUFINAMIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RUFINAMIDE", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA216549", "marketing_category": "ANDA", "marketing_start_date": "20221026", "listing_expiration_date": "20261231"}