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United States · US · US:33342-579_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f
Dimethyl Fumarate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1133342579961 KIT in 1 KIT (33342-579-96) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95)
Annotations
Orange Book
A210377
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": "33342-579_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f",
"productndc": "33342-579",
"dosage_form": "KIT",
"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": null,
"proprietary_name": "Dimethyl Fumarate",
"active_ingred_unit": null,
"application_number": "ANDA210377",
"marketing_category": "ANDA",
"nonproprietary_name": "Dimethyl Fumarate",
"start_marketing_date": "20250627",
"active_numerator_strength": null
}Access this data programmatically
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