FDA Orange Book
Is there a generic for Droxia?
Droxia contains hydroxyurea. 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 Droxia (hydroxyurea).
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Droxia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 300MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 400MG | Marketed (Rx) | None | 0 | None |
NDA 016295, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Droxia NDC codes
Questions
Is there a generic for Droxia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Droxia (hydroxyurea).
What is the generic name for Droxia?
The active ingredient in Droxia is hydroxyurea, 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 Droxia and Hydroxyurea
- What is Hydroxyurea used for?FDA label uses
- Is Hydroxyurea a controlled substance?Federal schedule
- Generic for HydreaFDA Orange Book
- Generic for XromiFDA Orange Book
- Generic for SiklosFDA Orange Book
- Antimetabolites listFDA drug class
- NDC 61269-402Droxia NDC record
- NDC 61269-403Droxia NDC record
- NDC 61269-404Droxia NDC record