rufinamide

Generic: rufinamide

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

Drug Facts

Product Profile

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

rufinamide 200 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-713
Product ID 68462-713_18421d5f-9e93-4abb-8abe-855bab5d243e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205075
Listing Expiration 2027-12-31
Marketing Start 2016-05-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462713
Hyphenated Format 68462-713

Supplemental Identifiers

RxCUI
824295 824301
UPC
0368462714089 0368462713082
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 ANDA205075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-713-30)
source: ndc

Packages (3)

68462-713-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05) 68462-713-08 120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08) 68462-713-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-713-30)

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": "18421d5f-9e93-4abb-8abe-855bab5d243e", "openfda": {"upc": ["0368462714089", "0368462713082"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824301"], "spl_set_id": ["da9ee326-a383-4d46-9d4e-fcc2be3d2680"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05)", "package_ndc": "68462-713-05", "marketing_start_date": "20160516"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08)", "package_ndc": "68462-713-08", "marketing_start_date": "20160516"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-713-30)", "package_ndc": "68462-713-30", "marketing_start_date": "20160516"}], "brand_name": "rufinamide", "product_id": "68462-713_18421d5f-9e93-4abb-8abe-855bab5d243e", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68462-713", "generic_name": "rufinamide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA205075", "marketing_category": "ANDA", "marketing_start_date": "20160516", "listing_expiration_date": "20271231"}