I 123 MIBG Meta Iodobenzylguanidine (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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I 123 MIBG META IODOBENZYLGUANIDINE
i 123 mibg injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-103
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IOBENGUANE SULFATE I-123 (IOBENGUANE I-123) IOBENGUANE SULFATE I-123 25 mCi
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC 0.21 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.02 mg
ASCORBIC ACID 37.6 mg
Product Characteristics
Color WHITE (White Powder) Score no score
Shape Size
Flavor Imprint Code
Contains preservative free
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51808-103-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (VIAL) in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/23/2012
Labeler — AnazaoHealth Corporation (011038762)
Establishment
Name Address ID/FEI Operations
AnazaoHealth Corporation 011038762 MANUFACTURE

Revised: 05/2012 AnazaoHealth Corporation

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