rufinamide

Generic: rufinamide

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

Drug Facts

Product Profile

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

rufinamide 400 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-804
Product ID 68180-804_3db88bc9-af10-4a67-86c5-9f034fa4db9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204964
Listing Expiration 2026-12-31
Marketing Start 2022-11-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180804
Hyphenated Format 68180-804

Supplemental Identifiers

RxCUI
824295 824301 2612668
UPC
0368180803164
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 ANDA204964 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16)
source: ndc

Packages (1)

68180-804-16 120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16)

Ingredients (1)

rufinamide (400 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": "3db88bc9-af10-4a67-86c5-9f034fa4db9a", "openfda": {"upc": ["0368180803164"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824301", "2612668"], "spl_set_id": ["2c2c8d41-1ae4-453a-b628-954ee0b3be5c"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16)", "package_ndc": "68180-804-16", "marketing_start_date": "20221128"}], "brand_name": "RUFINAMIDE", "product_id": "68180-804_3db88bc9-af10-4a67-86c5-9f034fa4db9a", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68180-804", "generic_name": "rufinamide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RUFINAMIDE", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "400 mg/1"}], "application_number": "ANDA204964", "marketing_category": "ANDA", "marketing_start_date": "20221128", "listing_expiration_date": "20261231"}