FDA Product

Intralipid

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Intralipid

FDA Product Code

65219-537

Regulatory Information

NDC Product Code

65219-537

Application Number

NDA019942

Marketing Category

C73594

Effective Date

February 15, 2023

Territorial Authority

USA

FDA Title

Intralipid 30% (A 30% I.V. Fat Emulsion)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerFresenius Kabi USA, LLC

DUNS Number

013547657

Active Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

EGG PHOSPHOLIPIDS

Code: 1Z74184RGV

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Quantity: 30 g in 100 mL

Code: 241ATL177A

Class Code: ACTIB

Active Moieties

SOYBEAN OIL

Code: 241ATL177A

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy