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United States · US · US:33342-349_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f
Dimethyl Fumarate
Orange BookUNIISPLATC L04AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeL04AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333423490960 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09)
- ndc11333423499414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94)
- ndc1133342349971 BLISTER PACK in 1 CARTON (33342-349-97) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210377
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": "33342-349_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f",
"productndc": "33342-349",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "210377",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "001",
"approval_date": "Jun 26, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "240MG",
"product_no": "002",
"approval_date": "Jun 26, 2024"
}
],
"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": "ANDA210377",
"marketing_category": "ANDA",
"nonproprietary_name": "Dimethyl Fumarate",
"start_marketing_date": "20240626",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code L04AX07.
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