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United States · US · US:70710-1205_548169c7-23fb-46e1-9a8d-556a00ee5cbc
dimethyl fumarate
Orange BookUNIISPLATC L04AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL04AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707101205660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-6)
- ndc11707101205846 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-8)
Annotations
UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210538
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": {
"b8e5184d-5d1d-0a89-e053-2995a90a2d6d": {
"match": "brand_token",
"title": "DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "9",
"published_date": "2026-05-11"
}
},
"productid": "70710-1205_548169c7-23fb-46e1-9a8d-556a00ee5cbc",
"productndc": "70710-1205",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "210538",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Sep 24, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "240MG",
"product_no": "002",
"approval_date": "Sep 24, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIMETHYL FUMARATE",
"proprietary_name": "dimethyl fumarate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210538",
"marketing_category": "ANDA",
"nonproprietary_name": "dimethyl fumarate",
"start_marketing_date": "20200928",
"active_numerator_strength": "240"
}Related drugs
Other records sharing ATC code L04AX07.
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