rufinamide

Generic: rufinamide

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler northstar rxllc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-261
Product ID 72603-261_1ccfda8b-0fa1-6b4a-e063-6294a90a15ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216841
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603261
Hyphenated Format 72603-261

Supplemental Identifiers

RxCUI
1092357
UPC
0372603261011
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 ANDA216841 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72603-261-01) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

72603-261-01 1 BOTTLE in 1 CARTON (72603-261-01) / 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": "1ccfda8b-0fa1-6b4a-e063-6294a90a15ad", "openfda": {"upc": ["0372603261011"], "unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["b682021c-74c3-4cc8-84af-acd94438397a"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-261-01)  / 460 mL in 1 BOTTLE", "package_ndc": "72603-261-01", "marketing_start_date": "20240801"}], "brand_name": "Rufinamide", "product_id": "72603-261_1ccfda8b-0fa1-6b4a-e063-6294a90a15ad", "dosage_form": "SUSPENSION", "product_ndc": "72603-261", "generic_name": "Rufinamide", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA216841", "marketing_category": "ANDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}