FDA Orange Book

Is there a generic for Pre-op?

Pre-op contains hexachlorophene. 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 Pre-op (hexachlorophene).

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Pre-op products in the Orange Book

Pre-op products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
sponge, topical480MGMarketed (Rx)AT0None

NDA 017433, held by DAVIS AND GECK DIV AMERICAN CYANAMID CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Questions

Is there a generic for Pre-op?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Pre-op (hexachlorophene).

What is the generic name for Pre-op?

The active ingredient in Pre-op is hexachlorophene, 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.

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