LumaSon

Orange BookUNIISPL

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

Identification

ManufacturerBRACCO DIAGNOSTICS INC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0270709707
20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL

Annotations

UNII (FDA Substance ID)

EAG959U971

DISTEAROYLPHOSPHATIDYLCHOLINE, DL-

RxCUI 1426932

Orange Book

N203684

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "EAG959U971",
    "rxcui": "1426932",
    "inchikey": "NRJAVPSFFCBXDT-UHFFFAOYSA-N",
    "display_name": "DISTEAROYLPHOSPHATIDYLCHOLINE, DL-",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; INTRAVESICAL",
  "spl_meta": {
    "69822a55-226c-f133-e3b8-2b5826667c5b": {
      "match": "brand_token",
      "title": "LUMASON (SULFUR HEXAFLUORIDE) KIT LUMASON (SULFUR HEXAFLUORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "10",
      "published_date": "2025-12-25"
    }
  },
  "productid": "0270-7097_5407234f-5a9d-9a66-2e42-6629c0c74aec",
  "productndc": "0270-7097",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "203684",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60.7MG/25MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE",
  "proprietary_name": "LumaSon",
  "active_ingred_unit": "mg/mg; mg/mg; mg/mg",
  "application_number": "NDA203684",
  "marketing_category": "NDA",
  "nonproprietary_name": "SULFUR HEXAFLUORIDE",
  "start_marketing_date": "20210401",
  "active_numerator_strength": ".19; .19; 60.7"
}

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