NDC Code(s) : 63323-147-10
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PeditraceZINC, COPPER, MANGANESE, SELENIUM, FLUORINE, and IODINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-147
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC CHLORIDE(UNII: 86Q357L16B)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION250 ug in 1 mL
CUPRIC CHLORIDE(UNII: S2QG84156O)
(CUPRIC CATION - UNII:8CBV67279L) 		CUPRIC CATION20 ug in 1 mL
MANGANESE CHLORIDE(UNII: QQE170PANO)
(MANGANESE CATION (2+) - UNII:H6EP7W5457) 		MANGANESE CATION (2+)1 ug in 1 mL
SODIUM SELENITE(UNII: HIW548RQ3W)
(SELENITE ION - UNII:KXO0259XJ1) 		SELENITE ION2 ug in 1 mL
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION57 ug in 1 mL
POTASSIUM IODIDE(UNII: 1C4QK22F9J)
(IODIDE ION - UNII:09G4I6V86Q) 		POTASSIUM IODIDE1 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM(UNII: 9NEZ333N27)70 ug in 1 mL
POTASSIUM(UNII: RWP5GA015D)0.31 ug in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-147-1010 in 1 CARTON
110 mL in 1 VIAL, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 05/09/2013

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Peditrace 10 mL Vial Label

Peditrace™

10 ml

Concentrate for solution for infusion

vial-lyv1981 

 

 

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Peditrace 10 mL Vial Carton Panel

10 vials of 10 ml

Peditrace™

Concentrate for solution for infusion

 

vial-lyv1981