intralipid

Generic: i.v. fat emulsion

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name intralipid
Generic Name i.v. fat emulsion
Labeler baxter healthcare corporation
Dosage Form EMULSION
Routes
INTRAVENOUS
Active Ingredients

soybean oil 20 g/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0519
Product ID 0338-0519_a34dffef-567f-47fe-9f33-3370819874c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018449
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 03380519
Hyphenated Format 0338-0519

Supplemental Identifiers

RxCUI
200317 805127 1799694 1799696 1799704 1799706 1799724 1799725
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 NDA018449 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 g/100mL
source: ndc
Packaging
  • 250 mL in 1 BAG (0338-0519-09)
  • 500 mL in 1 BAG (0338-0519-13)
  • 100 mL in 1 BAG (0338-0519-58)
source: ndc

Packages (3)

0338-0519-09 250 mL in 1 BAG (0338-0519-09) 0338-0519-13 500 mL in 1 BAG (0338-0519-13) 0338-0519-58 100 mL in 1 BAG (0338-0519-58)

Ingredients (1)

soybean oil (20 g/100mL)

Linked Drug Pages (3)

Intralipid ndc-match (0.9) Intralipid ndc-match (0.9) Intralipid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a34dffef-567f-47fe-9f33-3370819874c8", "openfda": {"nui": ["N0000191261", "M0012553"], "unii": ["241ATL177A"], "rxcui": ["200317", "805127", "1799694", "1799696", "1799704", "1799706", "1799724", "1799725"], "spl_set_id": ["a69c82da-15ba-4d4d-8d7f-871dc3981eb8"], "pharm_class_cs": ["Lipids [CS]"], "pharm_class_epc": ["Lipid Emulsion [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BAG (0338-0519-09)", "package_ndc": "0338-0519-09", "marketing_start_date": "20040401"}, {"sample": false, "description": "500 mL in 1 BAG (0338-0519-13)", "package_ndc": "0338-0519-13", "marketing_start_date": "20040401"}, {"sample": false, "description": "100 mL in 1 BAG (0338-0519-58)", "package_ndc": "0338-0519-58", "marketing_start_date": "20040401"}], "brand_name": "Intralipid", "product_id": "0338-0519_a34dffef-567f-47fe-9f33-3370819874c8", "dosage_form": "EMULSION", "pharm_class": ["Lipid Emulsion [EPC]", "Lipids [CS]"], "product_ndc": "0338-0519", "generic_name": "I.V. Fat Emulsion", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Intralipid", "active_ingredients": [{"name": "SOYBEAN OIL", "strength": "20 g/100mL"}], "application_number": "NDA018449", "marketing_category": "NDA", "marketing_start_date": "20040401", "listing_expiration_date": "20261231"}