Dimethyl Fumarate

Orange BookUNIISPLATC L04AX07

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeL04AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965108314
14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-083-14)

Annotations

UNII (FDA Substance ID)

FO2303MNI2

DIMETHYL FUMARATE

RxCUI 1373478

Orange Book

A210385

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": "59651-083_4d4ea332-4695-4c8c-ba54-c6e24fdee31c",
  "productndc": "59651-083",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "210385",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "002",
        "approval_date": "Dec 22, 2022"
      }
    ],
    "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": "ANDA210385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dimethyl Fumarate",
  "start_marketing_date": "20221222",
  "active_numerator_strength": "120"
}

Related drugs

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