dimethyl fumarate

Generic: dimethyl fumarate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimethyl fumarate
Generic Name dimethyl fumarate
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dimethyl fumarate 240 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-138
Product ID 82009-138_425dfa4b-ae5d-578b-e063-6394a90a4d3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210500
Listing Expiration 2026-12-31
Marketing Start 2024-06-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009138
Hyphenated Format 82009-138

Supplemental Identifiers

RxCUI
1373491
UPC
0382009138602
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 ANDA210500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (82009-138-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

82009-138-60 1 BOTTLE in 1 CARTON (82009-138-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "425dfa4b-ae5d-578b-e063-6394a90a4d3b", "openfda": {"upc": ["0382009138602"], "unii": ["FO2303MNI2"], "rxcui": ["1373491"], "spl_set_id": ["39150ef0-ba48-4719-b7fd-9beb4d4ad3ce"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82009-138-60)  / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "82009-138-60", "marketing_start_date": "20240615"}], "brand_name": "DIMETHYL FUMARATE", "product_id": "82009-138_425dfa4b-ae5d-578b-e063-6394a90a4d3b", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "82009-138", "generic_name": "DIMETHYL FUMARATE", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIMETHYL FUMARATE", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "240 mg/1"}], "application_number": "ANDA210500", "marketing_category": "ANDA", "marketing_start_date": "20240615", "listing_expiration_date": "20261231"}