Tecfidera

Orange BookSPL

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

Identification

ManufacturerBiogen Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6440600703
1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

Orange Book

N204063

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "665d7e74-036c-5f68-5b67-ab84b9b49151": {
      "match": "brand_token",
      "title": "TECFIDERA (DIMETHYL FUMARATE) KIT TECFIDERA (DIMETHYL FUMARATE) CAPSULE [BIOGEN INC.]",
      "spl_version": "55",
      "published_date": "2025-06-11"
    }
  },
  "productid": "64406-007_521e4305-9450-42a4-881b-05946acaa8fa",
  "productndc": "64406-007",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204063",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "002",
        "approval_date": "Mar 27, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tecfidera",
  "active_ingred_unit": null,
  "application_number": "NDA204063",
  "marketing_category": "NDA",
  "nonproprietary_name": "dimethyl fumarate",
  "start_marketing_date": "20130327",
  "active_numerator_strength": null
}

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