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Drug Product Composition: Berubigen

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$ API Ref.Price (USD/KG) : 1,853Xls

USFDA APPLICATION NUMBER - 18920 / DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
(.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)
.ALPHA.-TOCOPHEROL, DL-7mg in 5
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R)
ASCORBIC ACID80mg in 5
BIOTIN(UNII: 6SO6U10H04)
(BIOTIN - UNII:6SO6U10H04)
BIOTIN20ug in 5
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204)
CYANOCOBALAMIN1ug in 5
DEXPANTHENOL(UNII: 1O6C93RI7Z)
(DEXPANTHENOL - UNII:1O6C93RI7Z)
DEXPANTHENOL5mg in 5
ERGOCALCIFEROL(UNII: VS041H42XC)
(ERGOCALCIFEROL - UNII:VS041H42XC)
ERGOCALCIFEROL10ug in 5
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8)
FOLIC ACID140ug in 5
NIACINAMIDE(UNII: 25X51I8RD4)
(NIACINAMIDE - UNII:25X51I8RD4)
NIACINAMIDE17mg in 5
PHYTONADIONE(UNII: A034SE7857)
(PHYTONADIONE - UNII:A034SE7857)
PHYTONADIONE200ug in 5
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z)
PYRIDOXINE1mg in 5
RETINOL(UNII: G2SH0XKK91)
(RETINOL - UNII:G2SH0XKK91)
RETINOL0.7mg in 5
RIBOFLAVIN 5'-PHOSPHATE SODIUM(UNII: 20RD1DZH99)
(FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)
FLAVIN MONONUCLEOTIDE1.4mg in 5
THIAMINE HYDROCHLORIDE(UNII: M572600E5P)
(THIAMINE ION - UNII:4ABT0J945J)
THIAMINE ION1.2mg in 5

Inactive Ingredients

Ingredient Name
Hospira, Inc.
BUTYLATED HYDROXYANISOLE(REK4960K2U)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
MANNITOL(3OWL53L36A)
POLYSORBATE 20(7T1F30V5YH)
POLYSORBATE 80(6OZP39ZG8H)
SODIUM HYDROXIDE(55X04QC32I)