Medicine
Hydroxychloroquine 200 mg tablet
Hydroxychloroquine 200 mg tablet is a generic prescription medicine for oral use, made by 26 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 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Hydroxychloroquine
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 130 more
- Manufacturers
- Zydus LifesciencesIndiaIpca LaboratoriesIndiaLaurus LabsIndiaAccord HealthcareIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackRising Pharma HoldingsAmneal Pharmaceuticals NY26 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01BA02 Hydroxychloroquine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 January 2008
- Identifiers
- RxCUI 979092, 1119312, 2569281 +1DailyMed set ID 68d6439d-b927-47e6-86ef-20e572e81941, 04139607-f7c0-4fe1-a210-ffa5af347d56, ebe00e35-ed3d-40f4-9a93-a37b0da01ddb +37NDC 71335-3142, 82619-131, 0904-7046 +37Application ANDA040150, ANDA210441, ANDA210959 +8
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
A sample of 40 packs from 26 labelers. The register lists 133 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65841-633-01 | Zydus LifesciencesIndia | 3 January 2008 |
| 500 tablet, film coated in 1 bottle | 65841-633-05 | Zydus LifesciencesIndia | 3 January 2008 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65841-633-30 | Zydus LifesciencesIndia | 3 January 2008 |
| 100 tablet, film coated in 1 bottle | 68382-096-01 | Zydus LifesciencesIndia | 3 January 2008 |
| 500 tablet, film coated in 1 bottle | 68382-096-05 | Zydus LifesciencesIndia | 3 January 2008 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 68382-096-77 | Zydus LifesciencesIndia | 3 January 2008 |
| 100 tablet in 1 bottle | 16729-485-01 | Accord HealthcareIndia | 26 January 2021 |
| 500 tablet in 1 bottle | 16729-485-16 | Accord HealthcareIndia | 12 May 2020 |
| 100 tablet, film coated in 1 bottle, plastic | 59651-889-01 | Aurobindo PharmaIndia | 7 March 2025 |
| 500 tablet, film coated in 1 bottle, plastic | 59651-889-05 | Aurobindo PharmaIndia | 7 March 2025 |
| 100 tablet, film coated in 1 bottle | 43598-721-01 | Dr. Reddy's LaboratoriesIndia | 1 May 2018 |
| 500 tablet, film coated in 1 bottle | 43598-721-05 | Dr. Reddy's LaboratoriesIndia | 1 May 2018 |
| 100 tablet, film coated in 1 bottle | 83980-001-01 | Ipca LaboratoriesIndia | 3 June 2024 |
| 500 tablet, film coated in 1 bottle | 83980-001-05 | Ipca LaboratoriesIndia | 3 June 2024 |
| 1000 tablet, film coated in 1 bottle | 83980-001-10 | Ipca LaboratoriesIndia | 3 June 2024 |
| 10 tablet, film coated in 1 bottle | 83980-001-97 | Ipca LaboratoriesIndia | 3 June 2024 |
| 100 tablet, film coated in 1 bottle | 42385-971-01 | Laurus LabsIndia | 6 March 2023 |
| 500 tablet, film coated in 1 bottle | 42385-971-05 | Laurus LabsIndia | 6 March 2023 |
| 1000 tablet, film coated in 1 bottle | 42385-971-11 | Laurus LabsIndia | 6 March 2023 |
| 60 tablet, film coated in 1 bottle | 42385-971-60 | Laurus LabsIndia | 6 March 2023 |
| 500 tablet in 1 bottle | 57664-761-13 | Sun Pharmaceutical IndustriesIndia | 18 June 2018 |
| 100 tablet in 1 bottle | 57664-761-88 | Sun Pharmaceutical IndustriesIndia | 18 June 2018 |
| 100 tablet, film coated in 1 bottle | 60219-1544-1 | Amneal Pharmaceuticals NY | 17 May 2018 |
| 100 tablet, film coated in 1 bottle | 69238-1544-1 | Amneal Pharmaceuticals NY | 17 May 2018 |
| 500 tablet, film coated in 1 bottle | 69238-1544-5 | Amneal Pharmaceuticals NY | 17 September 2019 |
| 90 tablet in 1 bottle | 62135-752-90 | Chartwell RX | 28 May 2024 |
| 100 tablet in 1 bottle | 82619-131-01 | Creekwood Pharmaceuticals | 8 May 2025 |
| 500 tablet in 1 bottle | 82619-131-02 | Creekwood Pharmaceuticals | 8 May 2025 |
| 1000 tablet in 1 bottle | 82619-131-03 | Creekwood Pharmaceuticals | 8 May 2025 |
| 100 tablet, film coated in 1 bottle | 16571-112-01 | Rising Pharma Holdings | 29 May 2023 |
| 60 tablet, film coated in 1 bottle | 16571-112-06 | Rising Pharma Holdings | 29 May 2023 |
| 1000 tablet, film coated in 1 bottle | 16571-112-10 | Rising Pharma Holdings | 29 May 2023 |
| 500 tablet, film coated in 1 bottle | 16571-112-50 | Rising Pharma Holdings | 29 May 2023 |
| 100 tablet, film coated in 1 bottle | 0093-2401-01 | Teva Pharmaceuticals | 8 October 2020 |
| 100 tablet, film coated in 1 bottle | 71335-0897-1 | Bryant Ranch Prepack | 14 July 2020 |
| 30 tablet, film coated in 1 bottle | 71335-0897-2 | Bryant Ranch Prepack | 13 March 2020 |
| 60 tablet, film coated in 1 bottle | 71335-0897-3 | Bryant Ranch Prepack | 6 July 2018 |
| 180 tablet, film coated in 1 bottle | 71335-0897-4 | Bryant Ranch Prepack | 10 July 2018 |
| 90 tablet, film coated in 1 bottle | 71335-0897-5 | Bryant Ranch Prepack | 25 February 2019 |
| 120 tablet, film coated in 1 bottle | 71335-0897-6 | Bryant Ranch Prepack | 9 July 2024 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 18 April 1955 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Hydroxychloroquine 200 mg tablet.
Other strengths and forms of Hydroxychloroquine
Clinical summary
Hydroxychloroquine is an antimalarial indicated for the treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients, among other approved uses. MedsAcross supplies Hydroxychloroquine 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 HydroxychloroquineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Plaquenil prescribing information (Advanz Pharma) · U.S. National Library of Medicine, DailyMed
Need Hydroxychloroquine 200 mg tablet 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.