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United States · US · US:64406-005_521e4305-9450-42a4-881b-05946acaa8fa
TECFIDERA
Orange BookUNIISPLATC L04AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiogen Inc.
CountryUS (United States)
ATC codeL04AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164406005011 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) / 14 CAPSULE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
N204063
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FO2303MNI2",
"rxcui": "1373478",
"inchikey": "LDCRTTXIJACKKU-ONEGZZNKSA-N",
"display_name": "DIMETHYL FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"665d7e74-036c-5f68-5b67-ab84b9b49151": {
"match": "brand_token",
"title": "TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]",
"spl_version": "55",
"published_date": "2025-06-11"
}
},
"productid": "64406-005_521e4305-9450-42a4-881b-05946acaa8fa",
"productndc": "64406-005",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204063",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "120MG",
"product_no": "001",
"approval_date": "Mar 27, 2013"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "240MG",
"product_no": "002",
"approval_date": "Mar 27, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIMETHYL FUMARATE",
"proprietary_name": "TECFIDERA",
"active_ingred_unit": "mg/1",
"application_number": "NDA204063",
"marketing_category": "NDA",
"nonproprietary_name": "dimethyl fumarate",
"start_marketing_date": "20130327",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code L04AX07.
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