dimethyl fumarate

Generic: dimethyl fumarate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler aurobindo pharma limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 240 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-084
Product ID 59651-084_4d4ea332-4695-4c8c-ba54-c6e24fdee31c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210385
Listing Expiration 2026-12-31
Marketing Start 2022-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651084
Hyphenated Format 59651-084

Supplemental Identifiers

RxCUI
1373483 1373491
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 ANDA210385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-084-60)
source: ndc

Packages (1)

59651-084-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-084-60)

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": "4d4ea332-4695-4c8c-ba54-c6e24fdee31c", "openfda": {"unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491"], "spl_set_id": ["08f3a987-6571-42b3-854b-186d782b4494"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-084-60)", "package_ndc": "59651-084-60", "marketing_start_date": "20221222"}], "brand_name": "Dimethyl Fumarate", "product_id": "59651-084_4d4ea332-4695-4c8c-ba54-c6e24fdee31c", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "59651-084", "generic_name": "Dimethyl Fumarate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "240 mg/1"}], "application_number": "ANDA210385", "marketing_category": "ANDA", "marketing_start_date": "20221222", "listing_expiration_date": "20261231"}