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United States · US · US:0407-2707_37a56077-bf10-4afa-b405-7f80967f41e6

Optison

Orange BookUNIISPL

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

Identification

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

Packs · 2

  • ndc11
    0407270703
    5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE
  • ndc11
    0407270718
    18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
T8C6W1N6NW
HUMAN ALBUMIN MICROSPHERES
RxCUI 314302
Orange Book
N020899
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T8C6W1N6NW",
    "rxcui": "314302",
    "inchikey": null,
    "display_name": "HUMAN ALBUMIN MICROSPHERES",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "46bcf276-d423-408a-a410-f11383406a94": {
      "match": "brand_token",
      "title": "OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES (HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN) INJECTION, SOLUTION [GE HEALTHCARE INC.]",
      "spl_version": "24",
      "published_date": "2025-12-19"
    }
  },
  "productid": "0407-2707_37a56077-bf10-4afa-b405-7f80967f41e6",
  "productndc": "0407-2707",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020899",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Dec 31, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HUMAN ALBUMIN MICROSPHERES; PERFLUTREN",
  "proprietary_name": "Optison",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020899",
  "marketing_category": "NDA",
  "nonproprietary_name": "Human Albumin Microspheres and Perflutren",
  "start_marketing_date": "20020102",
  "active_numerator_strength": "10; .22"
}

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