Smoflipid
These highlights do not include all the information needed to use SMOFLIPID safely and effectively. See full prescribing information for SMOFLIPID. SMOFLIPID (lipid injectable emulsion), for intravenous use Initial U.S. Approval: 2016
Approved
Approval ID
e0e9d917-ff6f-488e-a6a8-0ad59dd17d80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Smoflipid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-820
Application NumberNDA207648
Product Classification
M
Marketing Category
C73594
G
Generic Name
Smoflipid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 30, 2019
FDA Product Classification
INGREDIENTS (10)
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
SODIUM OLEATEInactive
Code: 399SL044HN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SOYBEAN OILActive
Quantity: 6 g in 100 mL
Code: 241ATL177A
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESActive
Quantity: 6 g in 100 mL
Code: C9H2L21V7U
Classification: ACTIB
OLIVE OILActive
Quantity: 5 g in 100 mL
Code: 6UYK2W1W1E
Classification: ACTIB
FISH OILActive
Quantity: 3 g in 100 mL
Code: XGF7L72M0F
Classification: ACTIB
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 6/30/2023
RECENT MAJOR CHANGES
|
Dosage and Administration (2.1, 2.3) |
5/2023 |
|
Warnings and Precautions (5.1) |
5/2023 |