Drug
Who makes hydroxyurea?
14 companies list hydroxyurea as a human prescription drug, including under the names DROXIA, HYDREA, Siklos, XROMI. Forms: capsule; solution; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing hydroxyurea
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Waylis TherapeuticsUnited States | capsule | NDANDA016295 | 4 | 1 |
| H2-Pharma, LLC | capsule | NDANDA016295 | 4 | 0 |
| Medunik USA | tablet, film coated | NDANDA208843 | 2 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule | ANDAANDA075143 | 1 | 6 |
| Par Health USA, LLCIndia | capsule | ANDAANDA075340 | 1 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA075340 | 1 | 5 |
| Qilu Pharmaceutical Co., Ltd.China | capsule | ANDAANDA218021 | 1 | 5 |
| Nova Biologicals, Inc.United States | solution | NDANDA216593 | 1 | 2 |
| Coupler LLCUnited States | capsule | ANDAANDA218021 | 1 | 1 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA213438 | 1 | 1 |
| Leading Pharma, LLCUnited States | capsule | ANDAANDA213438 | 1 | 1 |
| Somerset Therapeutics Private LimitedIndia | capsule | ANDAANDA218021 | 1 | 1 |
| AvKARE | capsule | ANDAANDA075143 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule | ANDAANDA075340 | 1 | 0 |
Bulk ingredient listings
- Olon USA LLCItaly · 2 NDC
- Archimica S.p.A.Italy · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Genvion CorporationCanada · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITEDIndia · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Shandong Anxin Pharmaceutical Co., Ltd.China · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
1 unexpired patent lists hydroxyurea as the active ingredient, expiring between Dec 2041 and Dec 2041. Application holder: NOVA LABORATORIES LTD.
Enquiry
Common questions
- Who makes hydroxyurea?
- 14 companies list hydroxyurea as a human prescription drug in the openFDA NDC Directory, led by Waylis Therapeutics, H2-Pharma, LLC, Medunik USA, Teva Pharmaceutical Industries Ltd., Par Health USA, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic DROXIA?
- 10 companies list hydroxyurea under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies hydroxyurea active ingredient?
- 9 companies list hydroxyurea as a bulk ingredient, including Olon USA LLC, Archimica S.p.A., Darmerica, LLC, Genvion Corporation.