FDA Orange Book
Generic for Hydrea
Hydrea 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
Yes. The generic name for Hydrea is hydroxyurea. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Hydrea products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 500MG | Marketed (Rx) | AB | 4 | AB |
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.
Approved generic hydroxyurea
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 075143 | AB (A-rated, therapeutically equivalent) | October 16, 1998 | 500MG |
| PH HEALTH LTD | 075340 | AB (A-rated, therapeutically equivalent) | February 24, 1999 | 500MG |
| LEADING PHARMA LLC | 213438 | AB (A-rated, therapeutically equivalent) | April 8, 2020 | 500MG |
| QILU PHARMACEUTICAL CO LTD | 218021 | AB (A-rated, therapeutically equivalent) | March 6, 2024 | 500MG |
Hydrea NDC codes
Questions
Is there a generic for Hydrea?
Yes. The generic name for Hydrea is hydroxyurea. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Hydrea?
The active ingredient in Hydrea 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.