FDA Orange Book
Is there a generic for Ceretec?
Ceretec 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 Ceretec (technetium tc-99m exametazime kit).
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Ceretec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | N/A | Marketed (Rx) | None | 0 | None |
NDA 019829, held by GE HEALTHCARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ceretec NDC codes
Questions
Is there a generic for Ceretec?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ceretec (technetium tc-99m exametazime kit).
What is the generic name for Ceretec?
The active ingredient in Ceretec 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.