Intralipid
These highlights do not include all the information needed to use INTRALIPID safely and effectively. See full prescribing information for INTRALIPID. INTRALIPID 20% (lipid injectable emulsion), for intravenous useInitial U.S. Approval: 1975
Approved
Approval ID
61e025f1-a38e-4af2-9e18-13ea12977cf5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
I.V. Fat Emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-533
Application NumberNDA018449
Product Classification
M
Marketing Category
C73594
G
Generic Name
I.V. Fat Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SOYBEAN OILActive
Quantity: 20 g in 100 mL
Code: 241ATL177A
Classification: ACTIB
I.V. Fat Emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-531
Application NumberNDA018449
Product Classification
M
Marketing Category
C73594
G
Generic Name
I.V. Fat Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILActive
Quantity: 20 g in 100 mL
Code: 241ATL177A
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
I.V. Fat Emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-535
Application NumberNDA018449
Product Classification
M
Marketing Category
C73594
G
Generic Name
I.V. Fat Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SOYBEAN OILActive
Quantity: 20 g in 100 mL
Code: 241ATL177A
Classification: ACTIB