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United States Β· US Β· US:0270-7097_47b0f2df-0b6c-a221-750d-763d5ece665b

Lumason

Orange BookUNIISPL

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

Identification

ManufacturerBRACCO DIAGNOSTICS INC
CountryUS (United States)
ATC codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 1

  • ndc11
    0270709708
    20 VIAL in 1 BOX (0270-7097-08) / 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_47b0f2df-0b6c-a221-750d-763d5ece665b",
  "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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