ELEVIDYS

SPL

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

Identification

ManufacturerSarepta Therapeutics, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6092355160
1 KIT in 1 CARTON (60923-551-60) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 60 POUCH in 1 BOX / 1 SWAB in 1 POUCH

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3525abcd-fbd2-46c5-9706-cffdf2e8a361": {
      "match": "brand_token",
      "title": "ELEVIDYS (DELANDISTROGENE MOXEPARVOVEC-ROKL) KIT [SAREPTA THERAPEUTICS, INC.]",
      "spl_version": "11",
      "published_date": "2025-11-26"
    }
  },
  "productid": "60923-551_e3025a26-b6ff-4d3e-a8c0-fec9a8ae77cc",
  "productndc": "60923-551",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ELEVIDYS",
  "active_ingred_unit": null,
  "application_number": "BLA125781",
  "marketing_category": "BLA",
  "nonproprietary_name": "delandistrogene moxeparvovec-rokl",
  "start_marketing_date": "20230622",
  "active_numerator_strength": null
}

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