dimethyl fumarate

Generic: dimethyl fumarate

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler solco healthcare us, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 240 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-025
Product ID 43547-025_870120b7-7d68-4e5f-98cc-ac646624feb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210414
Listing Expiration 2026-12-31
Marketing Start 2022-10-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547025
Hyphenated Format 43547-025

Supplemental Identifiers

RxCUI
1373483 1373491
UPC
0343547025069 0343547024147
UNII
FO2303MNI2

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 dimethyl fumarate (source: ndc)
Generic Name dimethyl fumarate (source: ndc)
Application Number ANDA210414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-06)
  • 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46)
source: ndc

Packages (2)

43547-025-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-06) 43547-025-46 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46)

Ingredients (1)

dimethyl fumarate (240 mg/1)

Linked Drug Pages (1)

DIMETHYL FUMARATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "870120b7-7d68-4e5f-98cc-ac646624feb4", "openfda": {"upc": ["0343547025069", "0343547024147"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491"], "spl_set_id": ["a3677dce-a44b-481f-8a76-9ff3a4d42105"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-06)", "package_ndc": "43547-025-06", "marketing_start_date": "20221018"}, {"sample": false, "description": "46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46)", "package_ndc": "43547-025-46", "marketing_start_date": "20221018"}], "brand_name": "DIMETHYL FUMARATE", "product_id": "43547-025_870120b7-7d68-4e5f-98cc-ac646624feb4", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "43547-025", "generic_name": "dimethyl fumarate", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIMETHYL FUMARATE", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "240 mg/1"}], "application_number": "ANDA210414", "marketing_category": "ANDA", "marketing_start_date": "20221018", "listing_expiration_date": "20261231"}