FDA Orange Book
Generic for Fluorescite
Fluorescite contains fluorescein. 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 Fluorescite is fluorescein. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Fluorescite and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Fluorescite products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | Marketed (Rx) | AP | 3 | AP |
NDA 021980, held by ALCON LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluorescein
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NEXUS PHARMACEUTICALS LLC | 215709 | AP (A-rated, therapeutically equivalent) | September 25, 2023 | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| BPI LABS LLC | 220046 | AP (A-rated, therapeutically equivalent) | April 30, 2026 | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
| ZYDUS LIFESCIENCES GLOBAL FZE | 218651 | AP (A-rated, therapeutically equivalent) | June 1, 2026 | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
Fluorescite NDC codes
Questions
Is there a generic for Fluorescite?
Yes. The generic name for Fluorescite is fluorescein. 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 Fluorescite?
The active ingredient in Fluorescite is fluorescein, 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.