SPL UNCLASSIFIED SECTION.

Manufactured by: 3D Imaging Drug Design and Development LLC, 9015 Carti Way, Little Rock AR 72205Distributed by: 3D Imaging Drug Design and Development LLC, 9015 Carti Way, Little Rock AR 72205.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. No adverse reactions have been reported for Ammonia 13 Injection based on review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.. No adverse reactions have been reported for Ammonia 13 Injection based on review of the published literature, publicly available reference sources, and adverse drug reaction reporting system(6).To report SUSPECTED ADVERSE REACTIONS, contact 3D Imaging LLC at 501-353-2883 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Glass vial containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia 13 Injection in aqueous 0.9 sodium chloride solution (approximately mL volume)(3).Disposable plastic syringe (5 mL or 10 mL) containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia 13 Injection in aqueous 0.9 sodium chloride solution (approximately mL volume)(3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED. Ammonia 13 Injection is packaged in 10 mL multiple dose glass vials or or 10 mL single dose disposable plastic syringes containing between 1.11 GBq to 11.1 GBq (30 mCi to 300 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% sodium chloride injection solution in approximately mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with theoretical mass dose of 0.5- picomoles (8.47 16.94 picograms) of Ammonia.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package Inner and Outer Labels. Outer labels are exterior to the radiation shielding for the product vial and contain the direct labeling information. There is an inner label that can be printed and applied in advance to avoid radiation dose to the operators and is small enough to affix to the vial. The inner label contains the product name and batch number that positively connects it to the correct outer label. The outer label contains complete package label information and all dose information that is determined at the time of filling.. 10 mL Vial Outer Label. 10 mL Vial Outer Label 10 mL Vial Outer Label. 10 mL Syringe Outer Label. 10 mL Syringe Outer Label 10 mL Syringe Outer Label. mL Syringe Outer Label. mL Syringe Outer Label 5 mL Syringe Outer Label. Inner Label, All. Inner Label, All.