Quick answers
- What is Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling used for?
- The FDA-approved label (Ceretec, Medi-Physics Inc. dba GE Healthcare., January 10, 2024) says: “Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling?
- 2 companies list prescription products of Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling in the FDA NDC Directory, including Jubilant DraxImage Inc., dba Jubilant Radiopharma and Medi-Physics Inc. dba GE Healthcare..
What Kit for the preparation of technetium tc 99M exametazime for leukocyte labeling is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.
— FDA label: Ceretec, Medi-Physics Inc. dba GE Healthcare., effective January 10, 2024. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Drax Exametazime, Ceretec |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019829 CERETEC | Ge Healthcare | December 30, 1988 | 17, latest September 19, 2018 2018: Labeling · 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA208870 DRAX EXAMETAZIME | Jubilant | August 17, 2017 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 3c1eca7e-57a0-4876-8ed6-cd655ef5e296 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA019829, NDA208870 |
| Active ingredients (FDA) | TECHNETIUM TC-99M EXAMETAZIME |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ceretec, Medi-Physics Inc. dba GE Healthcare., effective January 10, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →