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United States · US · US:67877-557_75f80267-a5b2-4117-8003-05da3e461217
Dimethyl Fumarate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167877557391 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Annotations
Orange Book
A210440
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "67877-557_75f80267-a5b2-4117-8003-05da3e461217",
"productndc": "67877-557",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "210440",
"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": null,
"proprietary_name": "Dimethyl Fumarate",
"active_ingred_unit": null,
"application_number": "ANDA210440",
"marketing_category": "ANDA",
"nonproprietary_name": "Dimethyl Fumarate",
"start_marketing_date": "20200926",
"active_numerator_strength": null
}Access this data programmatically
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