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 SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-797
Product ID 68180-797_47c9752b-a06d-46af-a029-9213e2474378
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213457
Listing Expiration 2026-12-31
Marketing Start 2023-06-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180797
Hyphenated Format 68180-797

Supplemental Identifiers

RxCUI
1092357
UPC
0368180797012
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 ANDA213457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68180-797-01) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

68180-797-01 1 BOTTLE in 1 CARTON (68180-797-01) / 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": "47c9752b-a06d-46af-a029-9213e2474378", "openfda": {"upc": ["0368180797012"], "unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["1e671632-d5bd-499a-ba06-0d1dc0d99622"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68180-797-01)  / 460 mL in 1 BOTTLE", "package_ndc": "68180-797-01", "marketing_start_date": "20230622"}], "brand_name": "Rufinamide", "product_id": "68180-797_47c9752b-a06d-46af-a029-9213e2474378", "dosage_form": "SUSPENSION", "product_ndc": "68180-797", "generic_name": "Rufinamide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA213457", "marketing_category": "ANDA", "marketing_start_date": "20230622", "listing_expiration_date": "20261231"}