FDA Orange Book
Generic for Miraluma
Miraluma contains technetium tc-99m sestamibi 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 Miraluma is technetium tc-99m sestamibi kit. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Miraluma products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | N/A | Discontinued | None | 3 | AP |
NDA 019785, held by SHINE SPECT USA LLC. 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 sestamibi kit
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CURIUM US LLC | 078098 | AP (A-rated, therapeutically equivalent) | September 22, 2008 | N/A |
| CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES | 078809 | AP (A-rated, therapeutically equivalent) | April 28, 2009 | N/A |
| JUBILANT DRAXIMAGE USA INC | 078806 | AP (A-rated, therapeutically equivalent) | April 29, 2009 | N/A |
Miraluma NDC codes
Questions
Is there a generic for Miraluma?
Yes. The generic name for Miraluma is technetium tc-99m sestamibi kit. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Miraluma?
The active ingredient in Miraluma is technetium tc-99m sestamibi 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.