rufinamide

Generic: rufinamide

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rufinamide 200 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-598
Product ID 31722-598_c3c611a2-394b-4427-e053-2a95a90a433f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204993
Listing Expiration 2026-12-31
Marketing Start 2021-05-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722598
Hyphenated Format 31722-598

Supplemental Identifiers

RxCUI
824295 824301
UPC
0331722599122 0331722598125
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 ANDA204993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (31722-598-12)
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-598-30)
source: ndc

Packages (2)

31722-598-12 120 TABLET, FILM COATED in 1 BOTTLE (31722-598-12) 31722-598-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-598-30)

Ingredients (1)

rufinamide (200 mg/1)

Linked Drug Pages (1)

Rufinamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c3c611a2-394b-4427-e053-2a95a90a433f", "openfda": {"upc": ["0331722599122", "0331722598125"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824301"], "spl_set_id": ["afe24968-e078-46d6-a776-b2608734e03e"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (31722-598-12)", "package_ndc": "31722-598-12", "marketing_start_date": "20210511"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-598-30)", "package_ndc": "31722-598-30", "marketing_start_date": "20210511"}], "brand_name": "Rufinamide", "product_id": "31722-598_c3c611a2-394b-4427-e053-2a95a90a433f", "dosage_form": "TABLET, FILM COATED", "product_ndc": "31722-598", "generic_name": "Rufinamide", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA204993", "marketing_category": "ANDA", "marketing_start_date": "20210511", "listing_expiration_date": "20261231"}