rufinamide

Generic: rufinamide

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rufinamide
Generic Name rufinamide
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rufinamide 200 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-391
Product ID 42571-391_fbdca190-53fc-29e9-e053-6394a90abafe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216688
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571391
Hyphenated Format 42571-391

Supplemental Identifiers

RxCUI
824295 824301
UPC
0342571391126 0342571392123
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 ANDA216688 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (42571-391-12)
source: ndc

Packages (1)

42571-391-12 120 TABLET in 1 BOTTLE (42571-391-12)

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": "fbdca190-53fc-29e9-e053-6394a90abafe", "openfda": {"upc": ["0342571391126", "0342571392123"], "unii": ["WFW942PR79"], "rxcui": ["824295", "824301"], "spl_set_id": ["12fc41f9-b6a9-4bbd-afbe-5d269f5a42f6"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (42571-391-12)", "package_ndc": "42571-391-12", "marketing_start_date": "20230701"}], "brand_name": "RUFINAMIDE", "product_id": "42571-391_fbdca190-53fc-29e9-e053-6394a90abafe", "dosage_form": "TABLET", "product_ndc": "42571-391", "generic_name": "RUFINAMIDE", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RUFINAMIDE", "active_ingredients": [{"name": "RUFINAMIDE", "strength": "200 mg/1"}], "application_number": "ANDA216688", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}