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United States · US · US:0338-0519_75a235ef-1390-4ba5-abe5-27744d698537

Intralipid

Orange BookUNIISPL

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

Identification

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

Packs · 1

  • ndc11
    0338051914
    1000 mL in 1 BAG (0338-0519-14)

Annotations

UNII (FDA Substance ID)
241ATL177A
SOYBEAN OIL
RxCUI 9949
Orange Book
N020248
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": "0338-0519_75a235ef-1390-4ba5-abe5-27744d698537",
  "productndc": "0338-0519",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "020248",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20%",
        "product_no": "001",
        "approval_date": "Aug 7, 1996"
      }
    ],
    "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": "NDA020248",
  "marketing_category": "NDA",
  "nonproprietary_name": "I.V. Fat Emulsion",
  "start_marketing_date": "20040401",
  "active_numerator_strength": "20"
}

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