Medicine
Hydroxychloroquine 400 mg tablet
Hydroxychloroquine 400 mg tablet is a generic prescription medicine for oral use, made by 2 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 room temperature [20° to 25°C (68° to 77°F), allow for excursions…
Key facts
- Active ingredient (INN)
- Hydroxychloroquine
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaAccord HealthcareIndia
- Origin register
- US FDA, United States
- Storage
- Store at room temperature [20° to 25°C (68° to 77°F), allow for excursions between 15° and 30°C (59° and 86°F)]. Storage Dispense in a tight, light-resistant container as defined in the USP/NF.
- 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
- 28 September 2021
- Identifiers
- RxCUI 979092, 1119312, 2569281 +1DailyMed set ID 452092b4-7a8f-4d19-8113-f1c2a948d3d8, 84b00366-96ef-41e1-bac6-5d24acdb9e1dNDC 43598-131, 16729-563Application ANDA210441, ANDA213342
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 tablet in 1 bottle | 16729-563-01 | Accord HealthcareIndia | 28 September 2021 |
| 100 tablet, film coated in 1 bottle | 43598-131-01 | Dr. Reddy's LaboratoriesIndia | 24 October 2022 |
| 500 tablet, film coated in 1 bottle | 43598-131-05 | Dr. Reddy's LaboratoriesIndia | 24 October 2022 |
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
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 400 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.