Medicine
Hydrea 500 mg capsule
Hydrea 500 mg capsule is a prescription medicine containing Hydroxyurea for oral use, marketed by Waylis Therapeutics, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F).
Key facts
- Active ingredient (INN)
- Hydroxyurea
- Brand
- Hydrea
- Strength
- 500 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- Waylis Therapeutics
- Manufacturers
- Waylis TherapeuticsH2-Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX05 Hydroxyurea
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2009
- Identifiers
- RxCUI 105602, 197797DailyMed set ID 8d41152f-a98a-4abc-afdf-a909012434a0, 6053c775-68de-45e4-9af9-33b18fd0e140NDC 80725-810, 61269-835Application NDA016295
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle, plastic | 80725-810-10 | Waylis Therapeutics | 11 September 2025 |
| 100 capsule in 1 bottle | 61269-835-10 | H2-Pharma | 1 June 2009 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Hydroxyurea 500 mg capsule.
Other strengths and forms of Hydroxyurea
Clinical summary
Hydroxyurea 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. MedsAcross supplies Hydroxyurea for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about HydroxyureaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DROXIA prescribing information (H2-Pharma) · U.S. National Library of Medicine, DailyMed
- Siklos: European public assessment report (EPAR) · European Medicines Agency
- Xromi: European public assessment report (EPAR) · European Medicines Agency
Need Hydrea 500 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.