dimethyl fumarate

Generic: dimethyl fumarate

Labeler: civicascript llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dimethyl fumarate 120 mg/1

Manufacturer
CivicaScript LLC

Identifiers & Regulatory

Product NDC 82249-745
Product ID 82249-745_ca6c6bda-05ac-4a39-8356-86bdfa61e863
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210440
Listing Expiration 2026-12-31
Marketing Start 2025-06-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82249745
Hyphenated Format 82249-745

Supplemental Identifiers

RxCUI
1373483 1373491
UPC
0382249747602
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 ANDA210440 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82249-745-14)
source: ndc

Packages (1)

82249-745-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82249-745-14)

Ingredients (1)

dimethyl fumarate (120 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": "ca6c6bda-05ac-4a39-8356-86bdfa61e863", "openfda": {"upc": ["0382249747602"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491"], "spl_set_id": ["f3002b6a-841e-4247-9155-3acfb30cabcd"], "manufacturer_name": ["CivicaScript LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82249-745-14)", "package_ndc": "82249-745-14", "marketing_start_date": "20250611"}], "brand_name": "Dimethyl fumarate", "product_id": "82249-745_ca6c6bda-05ac-4a39-8356-86bdfa61e863", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "82249-745", "generic_name": "Dimethyl fumarate", "labeler_name": "CivicaScript LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210440", "marketing_category": "ANDA", "marketing_start_date": "20250611", "listing_expiration_date": "20261231"}