Medicine
Hydroxyurea 500 mg capsule
Hydroxyurea 500 mg capsule is a generic prescription medicine for oral use, made by 10 labelers, 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 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Hydroxyurea
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 100 blister pack, 30 capsules and 7 more
- Manufacturers
- American Health PackagingAvKARECouplerGolden State Medical SupplyLeading PharmaMajor PharmaceuticalsPar HealthQilu PharmaceuticalSomerset TherapeuticsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF).
- 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
- 19 October 1998
- Identifiers
- RxCUI 197797DailyMed set ID b9514ae5-79ae-4cc2-9d7f-c8f7806d1694, e76fd60e-7644-48c5-9857-3608a045000b, 4c4e1c2f-2143-44f3-8825-aeba42e755e4 +7NDC 0555-0882, 0904-6939, 69315-164 +7Application ANDA075143, ANDA075340, ANDA213438 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle, plastic | 69315-164-01 | Leading Pharma | 9 July 2020 |
| 100 capsule in 1 bottle | 49884-724-01 | Par Health | 24 February 1999 |
| 100 capsule in 1 bottle | 67184-0607-1 | Qilu Pharmaceutical | 6 March 2024 |
| 100 capsule in 1 bottle | 70069-820-01 | Somerset Therapeutics | 18 June 2024 |
| 100 capsule in 1 bottle | 0555-0882-02 | Teva Pharmaceuticals | 19 October 1998 |
| 100 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack | 68084-284-01 | American Health Packaging | 17 September 2008 |
| 100 capsule in 1 bottle | 42291-321-01 | AvKARE | 23 July 2013 |
| 30 capsule in 1 blister pack | 67046-1619-3 | Coupler | 2 December 2025 |
| 100 capsule in 1 bottle, plastic | 51407-909-01 | Golden State Medical Supply | 22 April 2024 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 0904-6939-61 | Major Pharmaceuticals | 24 February 1999 |
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 Hydroxyurea 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.