FDA Orange Book
Generic for DaTscan
DaTscan contains ioflupane i-123. 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 DaTscan is ioflupane i-123. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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DaTscan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 5mCi/2.5ML (2mCi/ML) | Marketed (Rx) | AP | 1 | AP |
NDA 022454, held by GE HEALTHCARE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ioflupane i-123
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CURIUM US LLC | 213792 | AP (A-rated, therapeutically equivalent) | March 30, 2022 | 5mCi/2.5ML (2mCi/ML) |
DaTscan NDC codes
Questions
Is there a generic for DaTscan?
Yes. The generic name for DaTscan is ioflupane i-123. 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 DaTscan?
The active ingredient in DaTscan is ioflupane i-123, 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.