FDA Product

Intralipid

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

Basic Information

Product Name

Intralipid

FDA Product Code

0338-0518

Regulatory Information

NDC Product Code

0338-0518

Application Number

NDA017643

Marketing Category

C73594

Effective Date

July 25, 2022

Territorial Authority

USA

FDA Title

Intralipid 10% (A 10% I.V. Fat Emulsion)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerBaxter Healthcare CORP

DUNS Number

005083209

Active Ingredients

EGG PHOSPHOLIPIDS

Code: 1Z74184RGV

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Quantity: 10 g in 100 mL

Code: 241ATL177A

Class Code: ACTIB

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

SOYBEAN OIL

Code: 241ATL177A

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy