The following Structured Product Label (SPL) was submitted to the FDA by 3d Imaging Drug Design And Development Llc for the product Ammonia (NDC 76451-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 6 adverse reactions, other, 3 dosage forms and strengths, 16 how supplied, package inner and outer labels, 10 ml vial outer label, 10 ml syringe outer label, 5 ml syringe outer label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.
Manufactured by: 3D Imaging Drug Design and Development LLC, 9015 Carti Way, Little Rock AR 72205
Distributed by: 3D Imaging Drug Design and Development LLC, 9015 Carti Way, Little Rock AR 72205
Glass vial containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (approximately 5 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 N 13 Injection in aqueous 0.9 % sodium chloride solution (approximately 5 mL volume)(3).
Ammonia N 13 Injection is packaged in 10 mL multiple dose glass vials or 5 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 8 mL volume. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5- 1 picomoles (8.47 - 16.94 picograms) of Ammonia.
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 a 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 (Vial10ammonia)
10 mL Syringe Outer Label
10 mL Syringe Outer Label (Syringe10ammonia)
5 mL Syringe Outer Label
5 mL Syringe Outer Label (Syringe5ammonia)
Inner Label, All (Innerall)
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