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United States · US · US:70771-1531_d8dceb92-b903-4b29-b3e6-4651fbc598fe

dimethyl fumarate

Orange BookUNIISPLATC L04AX07

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL04AX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7077115316
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-6)
  • ndc11
    7077115318
    46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-8)

Annotations

UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210538
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": "70771-1531_d8dceb92-b903-4b29-b3e6-4651fbc598fe",
  "productndc": "70771-1531",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "210538",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "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": "ANDA210538",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dimethyl fumarate",
  "start_marketing_date": "20200928",
  "active_numerator_strength": "240"
}

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