Medicine
Plaquenil 200 mg tablet
Plaquenil 200 mg tablet is a prescription medicine containing Hydroxychloroquine for oral use, marketed by Advanz Pharma, 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), allows excursions…
Key facts
- Active ingredient (INN)
- Hydroxychloroquine
- Brand
- Plaquenil
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 60 tablets, 4000 tablets and 6 more
- Marketing authorisation holder
- Advanz Pharma
- Manufacturers
- Advanz PharmaAphena Pharma Solutions - TennesseeProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store at room temperature [20° to 25°C (68° to 77°F), allows excursions 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
- 28 June 2013
- Identifiers
- RxCUI 979092, 979094DailyMed set ID 8aec894d-5711-4079-b167-240713bf04f2, 34496b43-05a2-45fb-a769-52b12e099341, eb26c050-fc41-4183-9f8c-86351335fa64NDC 71205-448, 59212-562, 71610-473Application NDA009768
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 tablet in 1 bottle | 59212-562-10 | Advanz Pharma | 28 June 2013 |
| 100 tablet in 1 bottle | 59212-562-11 | Advanz Pharma | 10 August 2020 |
| 60 tablet in 1 bottle | 59212-562-60 | Advanz Pharma | 5 January 2019 |
| 4000 tablet in 1 bottle | 71610-473-04 | Aphena Pharma Solutions - Tennessee | 3 April 2024 |
| 30 tablet in 1 bottle | 71610-473-30 | Aphena Pharma Solutions - Tennessee | 14 October 2020 |
| 60 tablet in 1 bottle | 71610-473-53 | Aphena Pharma Solutions - Tennessee | 14 October 2020 |
| 500 tablet in 1 bottle | 71610-473-74 | Aphena Pharma Solutions - Tennessee | 24 March 2023 |
| 180 tablet in 1 bottle | 71610-473-80 | Aphena Pharma Solutions - Tennessee | 8 December 2020 |
| 12 tablet in 1 bottle | 71205-448-12 | Proficient Rx | 8 April 2020 |
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 Plaquenil 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.