DIMETHYL FUMARATE

Orange BookSPL

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846257078
1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE

Annotations

Orange Book

A210309

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "68462-570_74611591-657b-40e8-8ae1-1e5533a05d97",
  "productndc": "68462-570",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "210309",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Oct 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "002",
        "approval_date": "Oct 6, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "DIMETHYL FUMARATE",
  "active_ingred_unit": null,
  "application_number": "ANDA210309",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dimethyl fumarate kit",
  "start_marketing_date": "20201006",
  "active_numerator_strength": null
}

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