Pediatric Infuvite Multiple Vitamins
These highlights do not include all the information needed to use INFUVITE PEDIATRIC safely and effectively. See full prescribing information for INFUVITE .INFUVITE PEDIATRIC (multiple vitamins injection), for intravenous useInitial U.S. Approval: 2001
Approved
Approval ID
4ff223f7-e076-4e81-8151-5c06724fabd9
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54643-9023
Application NumberNDA021265
Product Classification
M
Marketing Category
C73594
G
Generic Name
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 Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 28, 2016
FDA Product Classification
INGREDIENTS (20)
ASCORBIC ACIDActive
Quantity: 80 mg in 5 mL
Code: PQ6CK8PD0R
Classification: ACTIB
VITAMIN A PALMITATEActive
Quantity: 2300 [iU] in 5 mL
Code: 1D1K0N0VVC
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 5 mL
Code: 1C6V77QF41
Classification: ACTIB
RIBOFLAVIN 5'-PHOSPHATE SODIUMActive
Quantity: 1.4 mg in 5 mL
Code: 20RD1DZH99
Classification: ACTIM
DEXPANTHENOLActive
Quantity: 5 mg in 5 mL
Code: 1O6C93RI7Z
Classification: ACTIB
THIAMINE HYDROCHLORIDEActive
Quantity: 1.2 mg in 5 mL
Code: M572600E5P
Classification: ACTIR
PHYTONADIONEActive
Quantity: 0.2 mg in 5 mL
Code: A034SE7857
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1 mg in 5 mL
Code: 68Y4CF58BV
Classification: ACTIB
NIACINAMIDEActive
Quantity: 17 mg in 5 mL
Code: 25X51I8RD4
Classification: ACTIB
FOLIC ACIDActive
Quantity: 140 ug in 5 mL
Code: 935E97BOY8
Classification: ACTIB
BIOTINActive
Quantity: 20 ug in 5 mL
Code: 6SO6U10H04
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 1 ug in 5 mL
Code: P6YC3EG204
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 50 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Quantity: 75 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 7 [iU] in 5 mL
Code: 9E8X80D2L0
Classification: ACTIB
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54643-9031
Application NumberNDA021646
Product Classification
M
Marketing Category
C73594
G
Generic Name
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 Specifications
Effective DateOctober 28, 2016
FDA Product Classification