Ammonia N-13 Injection, Solution
Product Images NDC 52768-100

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Ammonia N-13 (NDC 52768-100). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Precision Nuclear Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Package (lead Shield) Label (30 mL Vial) (Nh31)

Package (lead Shield) Label (30 mL Vial) (Nh31)
The text describes a medical injection used for diagnostic purposes via intravenous usage. The injection is a non-pyrogenic, sterile solution containing ammonia N 13, which has a half-life of 9.96 minutes, and sodium chloride. The injection is stored upright in a shielded container and should be avoided if cloudy or has particulate matter. The correct dosage for the injection is calculated based on the date and time of calibration. The injection is only available through a prescription and is manufactured by Precision Nuclear, LLC.*
FDA Label Image

Vial Label (30 mL Vial) (Nh32)

Vial Label (30 mL Vial) (Nh32)
Ammonia N 13 Injection is a diagnostic solution intended for intravenous use only. It is supplied as a sterile, non-pyrogenic multiple-dose vial with cautionary notes given about its usage. The supplied solution has a limited expiry of 60 minutes after the End of Synthesis as specified in the Batch Record provided along with the vial. The radioactive solution contains 0.139 GBq-9.620 GBq (3.75 mCi-260 mCi) of no-carrier-added ammonia N 13 @ EOS* with 9mg of sodium chloride per ml. The product must be stored upright in a shielded container at 25 °C (77 °F), with excursions permitted to 15-30 °C (59-86 °F). Users are instructed to calculate the correct dosage from the date and time of calibration, as per EOS* on the above date. Manufacturing details, including batch records, calibration time, activity concentration, and test results, can be found in the provided documentation. The product is manufactured by Precision nuclear LLC and the contact number can be obtained from 423-567-0050 for calculating the correct dosage.*
FDA Label Image

Package (lead Shield) Label (50 mL Vial) (Nh33)

Package (lead Shield) Label (50 mL Vial) (Nh33)
Ammonia N 13 Injection is a sterile, non-pyrogenic diagnostic injection for intravenous use only. It has an expiration date of 60 minutes after End of Synthesis (EOS). Each mL contains no carrier added ammonia N 13 and 9 mg of sodium chloride. It must be aseptically withdrawn and handled, and not used if cloudy or contains particulate matter. The correct dosage should be calculated from the date and time of calibration. It is manufactured by Precision Nuclear, LLC and is available in a multiple-dose vial with NDC# 52768-100-50.*
FDA Label Image

Vial Label (50 mL Vial) (Nh34)

Vial Label (50 mL Vial) (Nh34)
Ammonia N 13 Injection is a medication for diagnostic use only, to be administered intravenously. It is a sterile, non-pyrogenic solution that comes in a multiple-dose vial with cautionary labelling. The solution contains no more than 0.139 GBq - 9.620 GBq (3.75 mCi - 260 mCi) of ammonia N13 at the end of synthesis along with 9 mg of sodium chloride. The product has a short half-life of 9.96 min and expires 60 minutes after the end of synthesis. The correct dosage is to be calculated based on the date and time of calibration that is specified in the batch record. The product is radioactive and manufacturing materials, batch record, activity concentration, calibration time end of synthesis, and test results are to be examined and recorded for use. The medication should be stored in a shielded container at 25 °C (77 °F) and within the permissible range of 15-30 °C (59-86 °F). Only use clear solutions, and carefully withdraw and handle doses aseptically. If the solution appears cloudy or has particulate matter, do not use it. The lot number, production date, and manufacturer are also provided.*
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Nh35

Nh35
Ammonia N 13 is a diagnostic injectable for intravenous use only. It is available in a sterile, non-pyrogenic single-dose syringe containing 3.75 mCi/mL to 260 mCi/mL of solution. The solution contains 0.139 GBq - 9.620 GBq (3.75 mCi - 260 mCi) of no carrier added ammonia N 13 @ EOS*. The lot and production details of the product can be checked on the batch record. The product should be used within 60 minutes after EOS* on the above date. The correct dosage should be calculated from the calibration date and time. The product is manufactured by Precision Nuclear, LLC and should be stored in a shielded container at 25 °C (77 °F), with excursions permitted to 15-30 °C (59-86 °F).*
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Nh36

Nh36
Ammonia N 13 injection is a radioactive diagnostic used for intravenous purposes only. It comes in a sterile, non-pyrogenic 5 mL single-dose syringe, with concentrations ranging from 3.75 mCi/mL to 260 mCi/mL at EOS. The expiry time of this injection is 60 minutes after EOS, and it should be stored in a shielded container at 25°C with excursions permitted to 15-30°C. Each mL contains 0.139 GBq - 9.620 GBq (3.75 mCi - 260 mCi) of no carrier added ammonia N 13 at EOS and 9 mg of sodium chloride. The correct dosage should be calculated based on the date and time of the calibration. Please do not use if cloudy or contains particulate matter. An NDC# is available for the injection.*
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Nh37

Nh37
Ammonia N 13 Injection is a diagnostic tool for intravenous use only. It has a shelf life of 60 minutes after EOS*. The dosages range from 3.75 mCi/mL to 260 mCi/mL. It is radioactive and sterile, non-pyrogenic. It comes in a 3 mL single-dose syringe with NDC# 52768-100-03. Store the injection in a shielded container at 25°C (77°F) with excursions allowed to 15°-30°C (59°F-86°F) in accordance with the USP Controlled Room Temperature. Calculate the appropriate dosage from the calibration date and time. If cloudy or contains particulate matter, do not use. The product is manufactured by Precision Nuclear, LLC, located at 830 Suncrest Dr. Gray, TN 37615.*
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Nh38

Nh38
Ammonia N 13 Injection is an intravenous radioactive diagnostic material that comes in single-dose syringe. Each mL contains 0.139 GBq - 9.620 GBq (3.75 mCi - 260 mCi) of no carrier added ammonia N 13 @ EOS* and 9 mg of 830 Suncrest Dr sodium chloride. It is sterile and non-pyrogenic with a life span of 60 minutes after End of the Synthesis (EOS*). The correct dosage is determined by calculating from the date and time of calibration. It is manufactured by Precision Nuclear, LLC., and lot # is provided. Store upright in a shielded container at 25 °C (77 °F), excursions are allowed to 15° to 30 °C (59° to 86 °F). If the solution is cloudy or contains particulate matter, avoid using the material. Contact your healthcare provider before using this product as it is a prescription drug.*
FDA Label Image

Chemical Structure (Ammonia 01)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.