Medicine
Primaquine 15 mg tablet
Primaquine 15 mg tablet is a generic prescription medicine for oral use, made by 5 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 25° C (77° F), excursions permitted to 15° - 30° C (59° - 86° F).
Key facts
- Active ingredient (INN)
- Primaquine
- Brand
- Sold under the generic name
- Strength
- 15 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 14 tablets and 4 more
- Manufacturers
- Unichem LaboratoriesIndiaIngenus PharmaceuticalsPD-Rx PharmaceuticalsAvKARESanofi-Aventis
- Origin register
- US FDA, United States
- Storage
- Store at 25° C (77° F), excursions permitted to 15° - 30° C (59° - 86° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01BA03 Primaquine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 April 2011
- Identifiers
- RxCUI 904170DailyMed set ID 0c8c2bc6-428b-40b6-8114-6df80290878d, 3f16166d-678e-51aa-e054-00144ff88e88, 09531382-2e06-4164-a7e1-169a1488788a +2NDC 76385-102, 43063-721, 50742-191 +2Application ANDA204476, ANDA206043, NDA008316
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 | 76385-102-01 | Unichem LaboratoriesIndia | 1 August 2014 |
| 100 tablet, film coated in 1 bottle, plastic | 50742-191-01 | Ingenus Pharmaceuticals | 23 January 2018 |
| 500 tablet, film coated in 1 bottle, plastic | 50742-191-05 | Ingenus Pharmaceuticals | 23 January 2018 |
| 100 tablet, film coated in 1 bottle | 0024-1596-01 | Sanofi-Aventis | 15 April 2011 |
| 100 tablet, film coated in 1 bottle | 42291-510-01 | AvKARE | 21 February 2019 |
| 14 tablet in 1 bottle, plastic | 43063-721-14 | PD-Rx Pharmaceuticals | 17 October 2016 |
| 28 tablet in 1 bottle, plastic | 43063-721-28 | PD-Rx Pharmaceuticals | 17 October 2016 |
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 23 January 1952 | 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
Clinical summary
Primaquine is an antimalarial indicated for the radical cure (prevention of relapse) of vivax malaria. It is available as tablets for oral use. MedsAcross supplies Primaquine 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 PrimaquineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Primaquine Phosphate prescribing information (Sanofi-Aventis) · U.S. National Library of Medicine, DailyMed
Need Primaquine 15 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.