Vitalipid N
Approved
Approval ID
704119cc-d2ad-408a-b213-fe232f7fe2ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 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.
VITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
PRODUCT DETAILS
NDC Product Code65219-335
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVENOUS
Effective DateAugust 18, 2023
Generic NameVITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
INGREDIENTS (9)
VITAMIN A PALMITATEActive
Quantity: 330 [iU] in 1 mL
Code: 1D1K0N0VVC
Classification: ACTIM
ErgocalciferolActive
Quantity: 20 [iU] in 1 mL
Code: VS041H42XC
Classification: ACTIB
PHYTONADIONEActive
Quantity: 15 ug in 1 mL
Code: A034SE7857
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 1 [iU] in 1 mL
Code: 7QWA1RIO01
Classification: ACTIB
VITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
PRODUCT DETAILS
NDC Product Code65219-339
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVENOUS
Effective DateAugust 18, 2023
Generic NameVITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
INGREDIENTS (9)
VITAMIN A PALMITATEActive
Quantity: 230 [iU] in 1 mL
Code: 1D1K0N0VVC
Classification: ACTIM
ErgocalciferolActive
Quantity: 40 [iU] in 1 mL
Code: VS041H42XC
Classification: ACTIB
PHYTONADIONEActive
Quantity: 20 ug in 1 mL
Code: A034SE7857
Classification: ACTIB
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 0.7 [iU] in 1 mL
Code: 7QWA1RIO01
Classification: ACTIB
VITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
PRODUCT DETAILS
NDC Product Code65219-337
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationINTRAVENOUS
Effective DateAugust 18, 2023
Generic NameVITAMIN A PALMITATE, Ergocalciferol, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE
INGREDIENTS (9)
ErgocalciferolActive
Quantity: 40 [iU] in 1 mL
Code: VS041H42XC
Classification: ACTIB
VITAMIN A PALMITATEActive
Quantity: 230 [iU] in 1 mL
Code: 1D1K0N0VVC
Classification: ACTIM
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 0.7 [iU] in 1 mL
Code: 7QWA1RIO01
Classification: ACTIB
PHYTONADIONEActive
Quantity: 20 ug in 1 mL
Code: A034SE7857
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT