FDA Product

Intralipid

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

Basic Information

Product Name

Intralipid

FDA Product Code

0338-0519

Regulatory Information

NDC Product Code

0338-0519

Application Number

NDA020248

Marketing Category

C73594

Effective Date

July 21, 2022

Territorial Authority

USA

FDA Title

Intralipid 20% (A 20% I.V. Fat Emulsion)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerBaxter Healthcare Corporation

DUNS Number

005083209

Active Ingredients

EGG PHOSPHOLIPIDS

Quantity: 1.2 g in 100 mL

Code: 1Z74184RGV

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Quantity: 20 g in 100 mL

Code: 241ATL177A

Class Code: ACTIB

GLYCERIN

Quantity: 2.25 g in 100 mL

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

SOYBEAN OIL

Code: 241ATL177A

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