FDA Orange Book
Generic for Draximage Dtpa
Draximage Dtpa contains technetium tc-99m pentetate 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
Yes. The generic name for Draximage Dtpa is technetium tc-99m pentetate kit. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Draximage Dtpa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | N/A | Marketed (Rx) | AP | 1 | AP |
NDA 018511, 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.
Approved generic technetium tc-99m pentetate kit
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CURIUM US LLC | 215146 | AP (A-rated, therapeutically equivalent) | March 26, 2025 | N/A |
Draximage Dtpa NDC codes
Questions
Is there a generic for Draximage Dtpa?
Yes. The generic name for Draximage Dtpa is technetium tc-99m pentetate kit. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Draximage Dtpa?
The active ingredient in Draximage Dtpa is technetium tc-99m pentetate 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.