MedPath
FDA Product

Pediatric Infuvite Multiple Vitamins

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Pediatric Infuvite Multiple Vitamins

54643-9023

Regulatory Information

54643-9023

NDA021265

C73594

October 28, 2016

USA

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

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

Sandoz Inc

005387188

Active Ingredients

ASCORBIC ACID

Quantity: 80 mg in 5 mL

Code: PQ6CK8PD0R

Class Code: ACTIB

VITAMIN A PALMITATE

Quantity: 2300 [iU] in 5 mL

Code: 1D1K0N0VVC

Class Code: ACTIM

CHOLECALCIFEROL

Quantity: 400 [iU] in 5 mL

Code: 1C6V77QF41

Class Code: ACTIB

RIBOFLAVIN 5'-PHOSPHATE SODIUM

Quantity: 1.4 mg in 5 mL

Code: 20RD1DZH99

Class Code: ACTIM

DEXPANTHENOL

Quantity: 5 mg in 5 mL

Code: 1O6C93RI7Z

Class Code: ACTIB

THIAMINE HYDROCHLORIDE

Quantity: 1.2 mg in 5 mL

Code: M572600E5P

Class Code: ACTIR

PHYTONADIONE

Quantity: 0.2 mg in 5 mL

Code: A034SE7857

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 1 mg in 5 mL

Code: 68Y4CF58BV

Class Code: ACTIB

NIACINAMIDE

Quantity: 17 mg in 5 mL

Code: 25X51I8RD4

Class Code: ACTIB

FOLIC ACID

Quantity: 140 ug in 5 mL

Code: 935E97BOY8

Class Code: ACTIB

BIOTIN

Quantity: 20 ug in 5 mL

Code: 6SO6U10H04

Class Code: ACTIB

CYANOCOBALAMIN

Quantity: 1 ug in 5 mL

Code: P6YC3EG204

Class Code: ACTIB

POLYSORBATE 80

Quantity: 50 mg in 5 mL

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

MANNITOL

Quantity: 75 mg in 5 mL

Code: 3OWL53L36A

Class Code: IACT

.ALPHA.-TOCOPHEROL ACETATE

Quantity: 7 [iU] in 5 mL

Code: 9E8X80D2L0

Class Code: ACTIB

Active Moieties

ASCORBIC ACID

Code: PQ6CK8PD0R

VITAMIN A

Code: 81G40H8B0T

THIAMINE ION

Code: 4ABT0J945J

CHOLECALCIFEROL

Code: 1C6V77QF41

PYRIDOXINE

Code: KV2JZ1BI6Z

FLAVIN MONONUCLEOTIDE

Code: 7N464URE7E

NIACINAMIDE

Code: 25X51I8RD4

DEXPANTHENOL

Code: 1O6C93RI7Z

.ALPHA.-TOCOPHEROL

Code: H4N855PNZ1

FOLIC ACID

Code: 935E97BOY8

BIOTIN

Code: 6SO6U10H04

PHYTONADIONE

Code: A034SE7857

CYANOCOBALAMIN

Code: P6YC3EG204

© Copyright 2025. All Rights Reserved by MedPath