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United States Β· US Β· US:65219-533_9b0d424f-8fab-4d03-9825-beeac68b29db

Intralipid

Orange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 1

  • ndc11
    6521953325
    10 BAG in 1 CASE (65219-533-25) / 250 mL in 1 BAG (65219-533-01)

Annotations

UNII (FDA Substance ID)
241ATL177A
SOYBEAN OIL
RxCUI 9949
Orange Book
N018449
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "241ATL177A",
    "rxcui": "9949",
    "inchikey": null,
    "display_name": "SOYBEAN OIL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "48c12fbe-c5e8-a1fc-e063-6294a90a15ae": {
      "match": "brand_token",
      "title": "INTRALIPID (I.V. FAT EMULSION) EMULSION [PROPHARMA DISTRIBUTION]",
      "spl_version": "1",
      "published_date": "2026-01-21"
    }
  },
  "productid": "65219-533_9b0d424f-8fab-4d03-9825-beeac68b29db",
  "productndc": "65219-533",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "018449",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOYBEAN OIL",
  "proprietary_name": "Intralipid",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA018449",
  "marketing_category": "NDA",
  "nonproprietary_name": "I.V. Fat Emulsion",
  "start_marketing_date": "20040401",
  "active_numerator_strength": "20"
}

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