dimethyl fumarate

Generic: dimethyl fumarate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dimethyl fumarate 120 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-349
Product ID 33342-349_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210377
Listing Expiration 2026-12-31
Marketing Start 2024-06-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342349
Hyphenated Format 33342-349

Supplemental Identifiers

RxCUI
1373483 1373491 1373497
UPC
0333342349095
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 ANDA210377 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09)
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94)
  • 1 BLISTER PACK in 1 CARTON (33342-349-97) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

33342-349-09 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09) 33342-349-94 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) 33342-349-97 1 BLISTER PACK in 1 CARTON (33342-349-97) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

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": "ef3e9cf5-b172-4e67-b621-dc94e9e9d93f", "openfda": {"upc": ["0333342349095"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373491", "1373497"], "spl_set_id": ["f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09)", "package_ndc": "33342-349-09", "marketing_start_date": "20240626"}, {"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94)", "package_ndc": "33342-349-94", "marketing_start_date": "20250627"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-349-97)  / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-349-97", "marketing_start_date": "20240626"}], "brand_name": "Dimethyl Fumarate", "product_id": "33342-349_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "33342-349", "generic_name": "Dimethyl Fumarate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimethyl Fumarate", "active_ingredients": [{"name": "DIMETHYL FUMARATE", "strength": "120 mg/1"}], "application_number": "ANDA210377", "marketing_category": "ANDA", "marketing_start_date": "20240626", "listing_expiration_date": "20261231"}