Smoflipid

Orange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6332382000
10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01)
ndc11
6332382010
6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05)
ndc11
6332382012
20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02)
ndc11
6332382050
12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03)
ndc11
6332382074
10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04)

Annotations

UNII (FDA Substance ID)

XGF7L72M0F

FISH OIL

RxCUI 4419

Orange Book

N207648

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "XGF7L72M0F",
    "rxcui": "4419",
    "inchikey": null,
    "display_name": "FISH OIL",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e0e9d917-ff6f-488e-a6a8-0ad59dd17d80": {
      "match": "brand_token",
      "title": "SMOFLIPID INJECTION, EMULSION [FRESENIUS KABI USA, LLC]",
      "spl_version": "11",
      "published_date": "2025-09-17"
    }
  },
  "productid": "63323-820_9fd35691-76ee-486c-bd65-b47d3df2fef4",
  "productndc": "63323-820",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "207648",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)",
        "product_no": "001",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)",
        "product_no": "002",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)",
        "product_no": "003",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)",
        "product_no": "004",
        "approval_date": "Aug 10, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL",
  "proprietary_name": "Smoflipid",
  "active_ingred_unit": "g/100mL; g/100mL; g/100mL; g/100mL",
  "application_number": "NDA207648",
  "marketing_category": "NDA",
  "nonproprietary_name": "Smoflipid",
  "start_marketing_date": "20160713",
  "active_numerator_strength": "3; 6; 5; 6"
}

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