Adult Infuvite Multiple Vitamins
These highlights do not include all the information needed to use INFUVITE ADULT safely and effectively. See full prescribing information for INFUVITE ADULTINFUVITE ADULT (multiple vitamins injection), for intravenous useInitial U.S. Approval: 2003
Approved
Approval ID
f10e7c39-b9ce-4d3b-98e0-891ccb8d0b1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2016
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
PRODUCT DETAILS
NDC Product Code54643-7862
Application NumberNDA021163
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 28, 2016
Generic NameAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
INGREDIENTS (20)
THIAMINE HYDROCHLORIDEActive
Quantity: 6 mg in 10 mL
Code: M572600E5P
Classification: ACTIR
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 6 mg in 10 mL
Code: 68Y4CF58BV
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ASCORBIC ACIDActive
Quantity: 200 mg in 10 mL
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 200 [iU] in 10 mL
Code: 1C6V77QF41
Classification: ACTIB
VITAMIN A PALMITATEActive
Quantity: 3300 [iU] in 10 mL
Code: 1D1K0N0VVC
Classification: ACTIM
RIBOFLAVIN 5'-PHOSPHATE SODIUMActive
Quantity: 3.6 mg in 10 mL
Code: 20RD1DZH99
Classification: ACTIM
NIACINAMIDEActive
Quantity: 40 mg in 10 mL
Code: 25X51I8RD4
Classification: ACTIB
DEXPANTHENOLActive
Quantity: 15 mg in 10 mL
Code: 1O6C93RI7Z
Classification: ACTIB
FOLIC ACIDActive
Quantity: 600 ug in 10 mL
Code: 935E97BOY8
Classification: ACTIB
BIOTINActive
Quantity: 60 ug in 10 mL
Code: 6SO6U10H04
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 10 [iU] in 10 mL
Code: 9E8X80D2L0
Classification: ACTIB
PHYTONADIONEActive
Quantity: 150 ug in 10 mL
Code: A034SE7857
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 5 ug in 10 mL
Code: P6YC3EG204
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
PRODUCT DETAILS
NDC Product Code54643-7874
Application NumberNDA021559
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 28, 2016
Generic NameAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
INGREDIENTS (20)
ASCORBIC ACIDActive
Quantity: 200 mg in 10 mL
Code: PQ6CK8PD0R
Classification: ACTIB
VITAMIN A PALMITATEActive
Quantity: 3300 [iU] in 10 mL
Code: 1D1K0N0VVC
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 200 [iU] in 10 mL
Code: 1C6V77QF41
Classification: ACTIB
THIAMINE HYDROCHLORIDEActive
Quantity: 6 mg in 10 mL
Code: M572600E5P
Classification: ACTIR
RIBOFLAVIN 5'-PHOSPHATE SODIUMActive
Quantity: 3.6 mg in 10 mL
Code: 20RD1DZH99
Classification: ACTIM
NIACINAMIDEActive
Quantity: 40 mg in 10 mL
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 6 mg in 10 mL
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 600 ug in 10 mL
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 5 ug in 10 mL
Code: P6YC3EG204
Classification: ACTIB
PHYTONADIONEActive
Quantity: 150 ug in 10 mL
Code: A034SE7857
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXPANTHENOLActive
Quantity: 15 mg in 10 mL
Code: 1O6C93RI7Z
Classification: ACTIB
BIOTINActive
Quantity: 60 ug in 10 mL
Code: 6SO6U10H04
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 10 [iU] in 10 mL
Code: 9E8X80D2L0
Classification: ACTIB