Drax Exametazime Injection, Powder, Lyophilized, For Solution
Product Images NDC 65174-200

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Drax Exametazime (NDC 65174-200). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Jubilant Draximage Inc., Dba Jubilant Radiopharma, 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

Carton Label (Carton)

Packaging label for Drax Exametazime, a kit for the preparation of Technetium Tc 99m Exametazime for leukocyte labeling. The product is a lyophilized powder injection with a strength of 0.5 mg per vial. The label indicates a package of 5 single-dose vials and is manufactured for Jubilant DraxImage Inc. in Kirkland, Quebec, Canada. The label includes storage and usage instructions along with container contents.*

FDA Label Image

Chemical Formula (Exametazime 1)

Chemical structure diagram showing the molecular structure of exametazime, the active ingredient in Drax Exametazime, a kit for the preparation of Technetium Tc 99m Exametazime for leukocyte labeling. The structure depicts two stereoisomers with corresponding atomic groups labeled, including methyl (Me), nitrogen (N), oxygen (O), and hydrogen (H) atoms, as well as the molecular formula C13H28N4O2.*

FDA Label Image

Labeling Schematic 2 (Labeling Schematic 2)

Instructional diagram for the preparation of Technetium Tc 99m Exametazime for leukocyte labeling. It visually depicts sequential steps including reconstitution, mixing with white blood cells, incubation, centrifugation, washing, radioactivity measurement, and injection preparation. The final panel includes the Jubilant DraxImage Inc. logo and contact information.*

FDA Label Image

Labeling Schematic 1 (Labeling Schematic)

An instructional diagram for Drax Exametazime (Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling) showing 12 sequential steps for leukocyte preparation involving syringes, blood withdrawal, mixing, sedimentation, centrifugation, washing with NaCl, and transfer between tubes. Each step uses simple black-and-white illustrations with arrows and minimal text instructions.*

FDA Label Image

Lead Pot Label (Lead Pot Labels)

Label for Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling. The label indicates it is for intravenous use, marked Rx only, with spaces for Patient ID, Lot number, Date, Time, and Activity in MBq or mCi. It includes a caution symbol for radioactive material and instruction to see the package insert for preparation instructions. Labeler is Jubilant DraxImage Inc.*

FDA Label Image

Radiation Label (Radiation Label)

Label for Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling injection powder, lyophilized, for solution. The label indicates it is for intravenous use only and includes fields for lot number, date, time, activity in MBq and mCi, total volume, concentration, and expiry. Contains a radioactive material caution symbol. Storage instructions state to store between 15°C and 25°C before reconstitution and 20°C to 25°C after reconstitution, with use for leukocyte labeling within 30 minutes. Labeler is Jubilant DraxImage Inc.*

FDA Label Image

Vial Label 2 (Vial Label 2)

Text panel listing contents of the vial for Drax Exametazime, specifying 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (with detailed tin content limits), and 4.5 mg sodium chloride per vial.*

FDA Label Image

Vial Label (Vial Label)

Label for Drax Exametazime 0.5 mg/vial, a kit for the preparation of Technetium Tc 99m Exametazime for leukocyte labeling, injection, powder, lyophilized for solution. The label indicates single-dose vial and intravenous use, with storage instructions and manufacturer Jubilant DraxImage Inc., Kirkland, Quebec, Canada. Barcode and lot/expiration date area are also visible.*

FDA Label Image

Worksheet Page 2 (Worksheet 2)

Labeling Efficiency Worksheet for Drax Exametazime, Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling. The worksheet includes steps to assay original syringe, hot supernatant, and labeled WBCs, with calculations for labeling efficiency and process yield. It includes space for physician/technologist signature and date, and Jubilant DraxImage Inc. contact information.*

FDA Label Image

Worksheet Page 1 (Worksheet)

Radiochemical purity testing form for Drax Exametazime, the Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling. The form includes fields for patient ID, generator details, elution data, eluate dilution, preparation specifics, and radiochemical purity test results with defined systems and limits. It is labeled with Jubilant DraxImage Inc. contact information and branding.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.