FDA Orange Book
Is there a generic for Drax Exametazime?
Drax Exametazime contains technetium tc-99m exametazime kit. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Drax Exametazime (technetium tc-99m exametazime kit).
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Drax Exametazime products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | N/A | Marketed (Rx) | None | 0 | None |
NDA 208870, held by JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Drax Exametazime NDC codes
Questions
Is there a generic for Drax Exametazime?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Drax Exametazime (technetium tc-99m exametazime kit).
What is the generic name for Drax Exametazime?
The active ingredient in Drax Exametazime is technetium tc-99m exametazime kit, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.