RADICAVA ORS

Orange BookSPL

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

Identification

ManufacturerShionogi Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051023221
1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1)

Annotations

Orange Book

N215446

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11": {
      "match": "brand_token",
      "title": "RADICAVA (EDARAVONE) INJECTION RADICAVA ORS (EDARAVONE) KIT [SHIONOGI INC.]",
      "spl_version": "29",
      "published_date": "2026-05-11"
    }
  },
  "productid": "70510-2322_9f9d17c0-7426-4713-885d-fb22a34b7028",
  "productndc": "70510-2322",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215446",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "105MG/5ML",
        "product_no": "001",
        "approval_date": "May 12, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "RADICAVA ORS",
  "active_ingred_unit": null,
  "application_number": "NDA215446",
  "marketing_category": "NDA",
  "nonproprietary_name": "EDARAVONE",
  "start_marketing_date": "20220512",
  "active_numerator_strength": null
}

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