DEA schedule
Is hydroxyurea a controlled substance?
Federal schedule for hydroxyurea from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Hydroxyurea is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and hydroxyurea is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 21 prescription listings from 14 labelers, none with a DEA schedule |
| DEA controlled substances list | hydroxyurea is not on the list |
Hydroxyurea NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 61269-402 | DROXIA | capsule | 200 mg/1 | H2-Pharma LLC | None |
| 80725-820 | DROXIA | capsule | 200 mg/1 | Waylis Therapeutics LLC | None |
| 61269-403 | DROXIA | capsule | 300 mg/1 | H2-Pharma LLC | None |
| 80725-830 | DROXIA | capsule | 300 mg/1 | Waylis Therapeutics LLC | None |
| 61269-404 | DROXIA | capsule | 400 mg/1 | H2-Pharma LLC | None |
| 80725-840 | DROXIA | capsule | 400 mg/1 | Waylis Therapeutics LLC | None |
| 61269-835 | HYDREA | capsule | 500 mg/1 | H2-Pharma LLC | None |
| 80725-810 | HYDREA | capsule | 500 mg/1 | Waylis Therapeutics LLC | None |
| 71770-105 | Siklos | tablet, film coated | 100 mg/1 | Medunik | None |
| 71770-120 | Siklos | tablet, film coated | 1000 mg/1 | Medunik | None |
| 62484-0015 | XROMI | solution | 100 mg/mL | Nova Laboratories, Ltd. | None |
| 0555-0882 | HYDROXYUREA | capsule | 500 mg/1 | Teva Pharmaceuticals USA, Inc. | None |
| 0904-6939 | Hydroxyurea | capsule | 500 mg/1 | Major Pharmaceuticals | None |
| 42291-321 | HYDROXYUREA | capsule | 500 mg/1 | AvKARE | None |
| 49884-724 | Hydroxyurea | capsule | 500 mg/1 | Par Health USA, LLC | None |
| 51407-909 | HYDROXYUREA | capsule | 500 mg/1 | Golden State Medical Supply, Inc. | None |
| 67046-1619 | HYDROXYUREA | capsule | 500 mg/1 | Coupler LLC | None |
| 67184-0607 | HYDROXYUREA | capsule | 500 mg/1 | Qilu Pharmaceutical Co., Ltd. | None |
| 68084-284 | Hydroxyurea | capsule | 500 mg/1 | American Health Packaging | None |
| 69315-164 | HYDROXYUREA | capsule | 500 mg/1 | Leading Pharma, LLC | None |
| 70069-820 | HYDROXYUREA | capsule | 500 mg/1 | Somerset Therapeutics, LLC | None |
Questions
Is hydroxyurea a controlled substance?
No. Hydroxyurea is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and hydroxyurea is not on the DEA controlled substances list.
Is hydroxyurea a narcotic?
No. Hydroxyurea is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Antimetabolite.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Hydroxyurea
- What is Hydroxyurea used for?FDA label uses
- Generic for DroxiaFDA Orange Book
- Generic for HydreaFDA Orange Book
- Generic for XromiFDA Orange Book
- Generic for SiklosFDA Orange Book
- Antimetabolites listFDA drug class
- NDC 61269-402Hydroxyurea NDC record
- NDC 61269-403Hydroxyurea NDC record
- NDC 61269-404Hydroxyurea NDC record