FDA Orange Book
Generic for Choletec
Choletec contains technetium tc-99m mebrofenin 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 Choletec is technetium tc-99m mebrofenin 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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Choletec 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 018963, held by BRACCO DIAGNOSTICS INC. 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 mebrofenin kit
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 078242 | AP (A-rated, therapeutically equivalent) | January 29, 2008 | N/A |
Choletec NDC codes
Questions
Is there a generic for Choletec?
Yes. The generic name for Choletec is technetium tc-99m mebrofenin 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 Choletec?
The active ingredient in Choletec is technetium tc-99m mebrofenin 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.