DIMETHYL FUMARATE

Orange BookUNIISPLATC L04AX07

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeL04AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009052880
1 CAPSULE, DELAYED RELEASE in 1 KIT (50090-5288-0)

Annotations

UNII (FDA Substance ID)

FO2303MNI2

DIMETHYL FUMARATE

RxCUI 1373478

Orange Book

A210500

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": "50090-5288_43b9bf3a-1ec7-4ca5-9931-61528baadc39",
  "productndc": "50090-5288",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "210500",
    "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": "ANDA210500",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DIMETHYL FUMARATE",
  "start_marketing_date": "20200924",
  "active_numerator_strength": "240"
}

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