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United States · US · US:69238-1318_76c5e6b0-c799-45cf-adb6-2d3845639b62
Dimethyl Fumarate
Orange BookUNIISPLATC L04AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeL04AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238131841 BOTTLE in 1 CARTON (69238-1318-4) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210402
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": {
"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": "69238-1318_76c5e6b0-c799-45cf-adb6-2d3845639b62",
"productndc": "69238-1318",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "210402",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "001",
"approval_date": "Sep 24, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"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": "ANDA210402",
"marketing_category": "ANDA",
"nonproprietary_name": "Dimethyl Fumarate",
"start_marketing_date": "20200928",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code L04AX07.
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