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United States · US · US:24979-127_8b1210a2-c1ad-44b7-8afe-a5c55bfb5be8

dimethyl fumarate

Orange BookUNIISPLATC L04AX07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeL04AX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2497912702
    500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-127-02)
  • ndc11
    2497912721
    14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-127-21)

Annotations

UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210382
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": "24979-127_8b1210a2-c1ad-44b7-8afe-a5c55bfb5be8",
  "productndc": "24979-127",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "210382",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Oct 14, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "002",
        "approval_date": "Oct 14, 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": "ANDA210382",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dimethyl fumarate",
  "start_marketing_date": "20201201",
  "active_numerator_strength": "120"
}

Related drugs

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