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United States · US · US:68462-308_74611591-657b-40e8-8ae1-1e5533a05d97
DIMETHYL FUMARATE
Orange BookUNIISPLATC L04AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeL04AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116846230805500 CAPSULE in 1 BOTTLE (68462-308-05)
- ndc11684623086060 CAPSULE in 1 BOTTLE (68462-308-60)
- ndc11684623086846 CAPSULE in 1 BOTTLE (68462-308-68)
Annotations
UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210309
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": "68462-308_74611591-657b-40e8-8ae1-1e5533a05d97",
"productndc": "68462-308",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210309",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "001",
"approval_date": "Oct 6, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "240MG",
"product_no": "002",
"approval_date": "Oct 6, 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": "ANDA210309",
"marketing_category": "ANDA",
"nonproprietary_name": "dimethyl-fumarate",
"start_marketing_date": "20201006",
"active_numerator_strength": "240"
}Related drugs
Other records sharing ATC code L04AX07.
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