FDA Orange Book
Is there a generic for Prezcobix Ped?
Prezcobix Ped contains darunavir ethanolate and cobicistat. 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 Prezcobix Ped (darunavir ethanolate and cobicistat).
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Prezcobix Ped products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 90MG;EQ 600MG BASE | Marketed (Rx) | None | 0 | None |
NDA 220092, held by JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Prezcobix Ped NDC codes
Questions
Is there a generic for Prezcobix Ped?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prezcobix Ped (darunavir ethanolate and cobicistat).
What is the generic name for Prezcobix Ped?
The active ingredient in Prezcobix Ped is darunavir ethanolate and cobicistat, 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.