FDA Orange Book
Generic for Ak-fluor
Ak-fluor 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 Ak-fluor is fluorescein. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Ak-fluor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 500MG BASE/2ML (EQ 250MG BASE/ML) | Discontinued | None | 1 | None |
| injectable, intravenous | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | Marketed (Rx) | AP | 3 | AP |
NDA 022186, held by LONG GROVE PHARMACEUTICALS LLC. 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 | None (No TE code listed) | June 1, 2026 | EQ 500MG BASE/2ML (EQ 250MG BASE/ML), EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
Ak-fluor NDC codes
Questions
Is there a generic for Ak-fluor?
Yes. The generic name for Ak-fluor 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 Ak-fluor?
The active ingredient in Ak-fluor 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.