rufinamide

Generic: rufinamide

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler american health packaging
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-824
Product ID 60687-824_47baf1f7-9edd-d2d7-e063-6294a90a6bfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207363
Listing Expiration 2027-12-31
Marketing Start 2026-01-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687824
Hyphenated Format 60687-824

Supplemental Identifiers

RxCUI
1092357
UNII
WFW942PR79

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 ANDA207363 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (60687-824-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-824-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-824-42)
source: ndc

Packages (1)

60687-824-08 3 TRAY in 1 CASE (60687-824-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-824-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-824-42)

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": "47baf1f7-9edd-d2d7-e063-6294a90a6bfe", "openfda": {"unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["1a0b80de-754d-4e60-b5a9-b6daa323bf58"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (60687-824-08)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-824-48)  / 10 mL in 1 CUP, UNIT-DOSE (60687-824-42)", "package_ndc": "60687-824-08", "marketing_start_date": "20260106"}], "brand_name": "Rufinamide", "product_id": "60687-824_47baf1f7-9edd-d2d7-e063-6294a90a6bfe", "dosage_form": "SUSPENSION", "product_ndc": "60687-824", "generic_name": "Rufinamide", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA207363", "marketing_category": "ANDA", "marketing_start_date": "20260106", "listing_expiration_date": "20271231"}