Intralipid

Orange BookUNIISPL

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

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
0338051904
1000 mL in 1 BAG (0338-0519-04)

Annotations

UNII (FDA Substance ID)

241ATL177A

SOYBEAN OIL

RxCUI 9949

Orange Book

N020248

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_7f10161b-9f00-3f03-e053-2991aa0adcd4",
  "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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