intralipid

Generic: i.v. fat emulsion

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name intralipid
Generic Name i.v. fat emulsion
Labeler fresenius kabi usa, llc
Dosage Form EMULSION
Routes
INTRAVENOUS
Active Ingredients

soybean oil 20 g/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-539
Product ID 65219-539_18cca00d-c31b-4b61-98ed-6e65c82d3789
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020248
Listing Expiration 2026-12-31
Marketing Start 2004-04-01

Pharmacologic Class

Established (EPC)
lipid emulsion [epc]
Chemical Structure
lipids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219539
Hyphenated Format 65219-539

Supplemental Identifiers

RxCUI
200317 805127
UNII
241ATL177A
NUI
N0000191261 M0012553

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name intralipid (source: ndc)
Generic Name i.v. fat emulsion (source: ndc)
Application Number NDA020248 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 g/100mL
source: ndc
Packaging
  • 6 BAG in 1 CASE (65219-539-10) / 1000 mL in 1 BAG (65219-539-01)
source: ndc

Packages (1)

65219-539-10 6 BAG in 1 CASE (65219-539-10) / 1000 mL in 1 BAG (65219-539-01)

Ingredients (1)

soybean oil (20 g/100mL)

Linked Drug Pages (1)

Intralipid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "18cca00d-c31b-4b61-98ed-6e65c82d3789", "openfda": {"nui": ["N0000191261", "M0012553"], "unii": ["241ATL177A"], "rxcui": ["200317", "805127"], "spl_set_id": ["bdcc364b-77b2-4939-8add-03e5396d46c2"], "pharm_class_cs": ["Lipids [CS]"], "pharm_class_epc": ["Lipid Emulsion [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BAG in 1 CASE (65219-539-10)  / 1000 mL in 1 BAG (65219-539-01)", "package_ndc": "65219-539-10", "marketing_start_date": "20230217"}], "brand_name": "Intralipid", "product_id": "65219-539_18cca00d-c31b-4b61-98ed-6e65c82d3789", "dosage_form": "EMULSION", "pharm_class": ["Lipid Emulsion [EPC]", "Lipids [CS]"], "product_ndc": "65219-539", "generic_name": "I.V. Fat Emulsion", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Intralipid", "active_ingredients": [{"name": "SOYBEAN OIL", "strength": "20 g/100mL"}], "application_number": "NDA020248", "marketing_category": "NDA", "marketing_start_date": "20040401", "listing_expiration_date": "20261231"}