NutriLipid I.V. Fat Emulsion
Approved
Approval ID
193290b1-a0a1-4054-a22a-de5c9e7a8b73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2023
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Soybean Oil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0264-4460
Application NumberNDA019531
Product Classification
M
Marketing Category
C73594
G
Generic Name
Soybean Oil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 17, 2023
FDA Product Classification
INGREDIENTS (6)
SOYBEAN OILActive
Quantity: 20 g in 100 mL
Code: 241ATL177A
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 2.5 g in 100 mL
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Quantity: 1.2 g in 100 mL
Code: 1Z74184RGV
Classification: IACT
SODIUM OLEATEInactive
Quantity: 0.03 g in 100 mL
Code: 399SL044HN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT