Intralipid

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

January 9, 2019

Territorial Authority

USA

FDA Title

Intralipid 20% A 20% I.V. Fat Emulsion In Excel Container

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

EGG PHOSPHOLIPIDS

Quantity: 1.2 g in 100 mL

Code: 1Z74184RGV

Class Code: IACT

GLYCERIN

Quantity: 2.25 g in 100 mL

Code: PDC6A3C0OX

Class Code: IACT

SOYBEAN OIL

Quantity: 20 g in 100 mL

Code: 241ATL177A

Class Code: ACTIB

Active Moieties

SOYBEAN OIL

Code: 241ATL177A

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM HYDROXIDE

EGG PHOSPHOLIPIDS

GLYCERIN

Active Moieties

SOYBEAN OIL