FDA Orange Book

Is there a generic for Altafluor Benox?

Altafluor Benox contains fluorescein and benoxinate. 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 Altafluor Benox (fluorescein and benoxinate).

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Altafluor Benox products in the Orange Book

Altafluor Benox products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution/drops, ophthalmic0.4%;0.25%Marketed (Rx)None0None

NDA 208582, held by ALTAIRE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Altafluor Benox NDC codes

Questions

Is there a generic for Altafluor Benox?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Altafluor Benox (fluorescein and benoxinate).

What is the generic name for Altafluor Benox?

The active ingredient in Altafluor Benox is fluorescein and benoxinate, 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.

More on Altafluor Benox and Fluorescein and Benoxinate

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