rufinamide

Generic: rufinamide

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler ascend laboratories, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

rufinamide 40 mg/mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-673
Product ID 67877-673_32782da2-64b5-497c-a620-c5d301c8c592
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213410
Listing Expiration 2026-12-31
Marketing Start 2021-02-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877673
Hyphenated Format 67877-673

Supplemental Identifiers

RxCUI
1092357
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 ANDA213410 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (67877-673-62) / 460 mL in 1 BOTTLE
source: ndc

Packages (1)

67877-673-62 1 BOTTLE in 1 CARTON (67877-673-62) / 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": "32782da2-64b5-497c-a620-c5d301c8c592", "openfda": {"unii": ["WFW942PR79"], "rxcui": ["1092357"], "spl_set_id": ["a02ca527-bd8f-49ef-89fa-91fac154bffe"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (67877-673-62)  / 460 mL in 1 BOTTLE", "package_ndc": "67877-673-62", "marketing_start_date": "20210224"}], "brand_name": "Rufinamide", "product_id": "67877-673_32782da2-64b5-497c-a620-c5d301c8c592", "dosage_form": "SUSPENSION", "product_ndc": "67877-673", "generic_name": "Rufinamide", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rufinamide", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "40 mg/mL"}], "application_number": "ANDA213410", "marketing_category": "ANDA", "marketing_start_date": "20210224", "listing_expiration_date": "20261231"}