rufinamide

Generic: rufinamide

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

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler hikma pharmaceuticals usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0528
Product ID 0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207363
Listing Expiration 2026-12-31
Marketing Start 2020-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540528
Hyphenated Format 0054-0528

Supplemental Identifiers

RxCUI
1092357
UPC
0300540528638
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 ANDA207363 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

0054-0528-63 1 BOTTLE in 1 CARTON (0054-0528-63) / 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": "eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80", "openfda": {"upc": ["0300540528638"], "unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["8ef75997-06f6-441f-8320-a23bc13ca2d9"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0054-0528-63)  / 460 mL in 1 BOTTLE", "package_ndc": "0054-0528-63", "marketing_start_date": "20201101"}], "brand_name": "Rufinamide", "product_id": "0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80", "dosage_form": "SUSPENSION", "product_ndc": "0054-0528", "generic_name": "Rufinamide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA207363", "marketing_category": "ANDA", "marketing_start_date": "20201101", "listing_expiration_date": "20261231"}