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United States · US · US:64406-020_25e0bcfe-8df7-4a62-9db1-ba39a266e8bd

Vumerity

Orange BookUNIISPLATC L04AX09

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

Identification

ManufacturerBiogen Inc.
CountryUS (United States)
ATC codeL04AX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6440602003
    1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC
  • ndc11
    6440602007
    1 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
K0N0Z40J3W
DIROXIMEL FUMARATE
RxCUI 2261783
Orange Book
N211855
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K0N0Z40J3W",
    "rxcui": "2261783",
    "inchikey": "YIMYDTCOUQIDMT-SNAWJCMRSA-N",
    "display_name": "DIROXIMEL FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2d74414f-6b83-4ea2-9a95-3cecabbce774": {
      "match": "brand_token",
      "title": "VUMERITY (DIROXIMEL FUMARATE) CAPSULE [BIOGEN INC.]",
      "spl_version": "16",
      "published_date": "2025-06-02"
    }
  },
  "productid": "64406-020_25e0bcfe-8df7-4a62-9db1-ba39a266e8bd",
  "productndc": "64406-020",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211855",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "231MG",
        "product_no": "001",
        "approval_date": "Oct 29, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIROXIMEL FUMARATE",
  "proprietary_name": "Vumerity",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211855",
  "marketing_category": "NDA",
  "nonproprietary_name": "diroximel fumarate",
  "start_marketing_date": "20191029",
  "active_numerator_strength": "231"
}

Related drugs

Other records sharing ATC code L04AX09.

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