FDA Orange Book
Is there a generic for Tissueblue?
Tissueblue contains brilliant blue g. 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 Tissueblue (brilliant blue g). The Orange Book shows its last listed exclusivity ends December 20, 2026.
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Tissueblue products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, ophthalmic | 0.025% | Marketed (Rx) | None | 0 | None |
NDA 209569, held by DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tissueblue exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-282 | Orphan drug exclusivity | December 20, 2026 | 209569 |
Tissueblue NDC codes
Questions
Is there a generic for Tissueblue?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tissueblue (brilliant blue g). The Orange Book shows its last listed exclusivity ends December 20, 2026.
What is the generic name for Tissueblue?
The active ingredient in Tissueblue is brilliant blue g, 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.