tecfidera

Generic: dimethyl fumarate

Labeler: biogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tecfidera
Generic Name dimethyl fumarate
Labeler biogen inc.
Dosage Form KIT
Manufacturer
Biogen Inc.

Identifiers & Regulatory

Product NDC 64406-007
Product ID 64406-007_521e4305-9450-42a4-881b-05946acaa8fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204063
Listing Expiration 2026-12-31
Marketing Start 2013-03-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64406007
Hyphenated Format 64406-007

Supplemental Identifiers

RxCUI
1373483 1373489 1373491 1373493 1373497 1373498
UPC
0364406005015 0364406005107 0364406005084
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 tecfidera (source: ndc)
Generic Name dimethyl fumarate (source: ndc)
Application Number NDA204063 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 120 mg
  • 240 mg
source: label
Packaging
  • 1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

64406-007-03 1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

TECFIDERA, Tecfidera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "521e4305-9450-42a4-881b-05946acaa8fa", "openfda": {"upc": ["0364406005015", "0364406005107", "0364406005084"], "unii": ["FO2303MNI2"], "rxcui": ["1373483", "1373489", "1373491", "1373493", "1373497", "1373498"], "spl_set_id": ["665d7e74-036c-5f68-5b67-ab84b9b49151"], "manufacturer_name": ["Biogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (64406-007-03)  *  14 CAPSULE in 1 BOTTLE, PLASTIC *  46 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "64406-007-03", "marketing_start_date": "20130327"}], "brand_name": "Tecfidera", "product_id": "64406-007_521e4305-9450-42a4-881b-05946acaa8fa", "dosage_form": "KIT", "product_ndc": "64406-007", "generic_name": "dimethyl fumarate", "labeler_name": "Biogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tecfidera", "application_number": "NDA204063", "marketing_category": "NDA", "marketing_start_date": "20130327", "listing_expiration_date": "20261231"}