FDA Orange Book

Is there a generic for Orapred ODT?

Orapred ODT contains prednisolone. 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 Orapred ODT (prednisolone).

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Orapred ODT products in the Orange Book

Orapred ODT products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, orally disintegrating, oralEQ 10MG BASEMarketed (Rx)None0None
tablet, orally disintegrating, oralEQ 15MG BASEMarketed (Rx)None0None
tablet, orally disintegrating, oralEQ 30MG BASEMarketed (Rx)None0None

NDA 021959, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Orapred ODT NDC codes

Questions

Is there a generic for Orapred ODT?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Orapred ODT (prednisolone).

What is the generic name for Orapred ODT?

The active ingredient in Orapred ODT is prednisolone, 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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