Quick answers
- What is Hydroxyurea used for?
- The FDA-approved label (Droxia, H2-Pharma LLC, January 26, 2026) says: “DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydroxyurea have a boxed warning?
- Yes. The FDA label for Droxia has a boxed warning (“WARNING: MYELOSUPPRESSION AND MALIGNANCIES”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Hydroxyurea?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hydroxyurea been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hydroxyurea?
- 14 companies list prescription products of Hydroxyurea in the FDA NDC Directory, including Waylis Therapeutics LLC, H2-Pharma, LLC and Medunik.
What Hydroxyurea is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.
— FDA label: Droxia, H2-Pharma LLC, effective January 26, 2026. Read the full label on DailyMed →
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: MYELOSUPPRESSION AND MALIGNANCIES
. Read it on the full label →
4 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydroxyurea 100 mg tablet, film coated | Brand: Siklos | $6.19 per tablet |
| hydroxyurea 100 mg/mL solution | Brand: Xromi | $4.97 per mL |
| hydroxyurea 1000 mg tablet, film coated | Brand: Siklos | $62.11 per tablet |
| hydroxyurea 500 mg capsule | Generic | $0.1845 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Waylis Therapeutics LLC4 products
- H2-Pharma, LLC4 products
- Medunik2 products
- Qilu Pharmaceutical Co., Ltd.1 product
- Par Health USA, LLC1 product
- Golden State Medical Supply, Inc.1 product
- American Health Packaging1 product
- Somerset Therapeutics, LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- AvKARE1 product
- Coupler LLC1 product
- Leading Pharma, LLC1 product
- Nova Laboratories, Ltd1 product
- Major Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016295 DROXIA, HYDREA | Waylis Therap | December 7, 1967 | 43, latest June 20, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
| NDA208843 SIKLOS | Theravia | December 21, 2017 | 4, latest November 28, 2023 2023: Labeling · 2021: Efficacy · 2019: Labeling |
| NDA216593 XROMI | Nova Labs Ltd | April 4, 2024 | 1, latest December 23, 2024 2024: Labeling |
Generic approvals (4)
- ANDA075143Barr · October 16, 1998
- ANDA075340Ph Health · February 24, 1999
- ANDA213438Leading · April 8, 2020
- ANDA218021Qilu · March 6, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Droxia, H2-Pharma LLC, effective January 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →