Dimethyl fumarate

Orange BookUNIISPLATC L04AX07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeL04AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6787755610
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-10)
ndc11
6787755633
10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67877-556-33)
ndc11
6787755646
46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-46)
ndc11
6787755660
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-60)
ndc11
6787755690
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-90)

Annotations

UNII (FDA Substance ID)

FO2303MNI2

DIMETHYL FUMARATE

RxCUI 1373478

Orange Book

A210440

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": "67877-556_75f80267-a5b2-4117-8003-05da3e461217",
  "productndc": "67877-556",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "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": "DIMETHYL FUMARATE",
  "proprietary_name": "Dimethyl fumarate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210440",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dimethyl fumarate",
  "start_marketing_date": "20200926",
  "active_numerator_strength": "240"
}

Related drugs

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