Medicine
Primidone 50 mg tablet
Primidone 50 mg tablet is a generic prescription medicine for oral use, made by 19 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 to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Primidone
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 60 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaAphena Pharma Solutions - TennesseeOxford PharmaceuticalsAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkBryant Ranch PrepackCarnegie PharmaceuticalsLannettAdvagen PharmaChartwell RX19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AA03 Primidone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 May 2001
- Identifiers
- RxCUI 96304, 198150, 328176DailyMed set ID b3b94d2e-6a64-45b7-b0cb-0fde689240d8, e4e493bd-94d7-7e5a-e053-2995a90a2706, 182a424b-d142-48c9-996b-059c0885f528 +21NDC 72888-045, 51407-637, 72603-609 +20Application ANDA214896, ANDA084903, ANDA040866 +3
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 19 labelers. The register lists 63 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 55111-477-01 | Dr. Reddy's LaboratoriesIndia | 3 October 2008 |
| 500 tablet in 1 bottle | 55111-477-05 | Dr. Reddy's LaboratoriesIndia | 3 October 2008 |
| 30 tablet in 1 bottle | 55111-477-30 | Dr. Reddy's LaboratoriesIndia | 3 October 2008 |
| 60 tablet in 1 bottle | 55111-477-60 | Dr. Reddy's LaboratoriesIndia | 3 October 2008 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 55111-477-78 | Dr. Reddy's LaboratoriesIndia | 3 October 2008 |
| 100 tablet in 1 bottle | 72888-045-01 | Advagen Pharma | 28 June 2022 |
| 500 tablet in 1 bottle | 72888-045-05 | Advagen Pharma | 28 June 2022 |
| 100 tablet in 1 bottle | 65162-544-10 | Amneal Pharmaceuticals | 24 December 2009 |
| 1000 tablet in 1 bottle | 65162-544-11 | Amneal Pharmaceuticals | 24 December 2009 |
| 500 tablet in 1 bottle | 65162-544-50 | Amneal Pharmaceuticals | 24 December 2009 |
| 100 tablet in 1 bottle | 53746-544-01 | Amneal Pharmaceuticals of New York | 24 December 2009 |
| 500 tablet in 1 bottle | 53746-544-05 | Amneal Pharmaceuticals of New York | 24 December 2009 |
| 1000 tablet in 1 bottle | 53746-544-10 | Amneal Pharmaceuticals of New York | 24 December 2009 |
| 100 tablet in 1 bottle | 80005-117-11 | Carnegie Pharmaceuticals | 1 May 2024 |
| 500 tablet in 1 bottle | 80005-117-14 | Carnegie Pharmaceuticals | 1 May 2024 |
| 1000 tablet in 1 bottle | 80005-117-15 | Carnegie Pharmaceuticals | 1 May 2024 |
| 90 tablet in 1 bottle | 62135-468-90 | Chartwell RX | 11 April 2023 |
| 100 tablet in 1 bottle | 0527-1301-01 | Lannett | 24 May 2001 |
| 500 tablet in 1 bottle | 0527-1301-05 | Lannett | 24 May 2001 |
| 1000 tablet in 1 bottle | 0527-1301-10 | Lannett | 24 May 2001 |
| 90 tablet in 1 bottle, plastic | 69584-684-09 | Oxford Pharmaceuticals | 1 November 2026 |
| 100 tablet in 1 bottle, plastic | 69584-684-10 | Oxford Pharmaceuticals | 22 February 2021 |
| 500 tablet in 1 bottle, plastic | 69584-684-50 | Oxford Pharmaceuticals | 22 February 2021 |
| 1000 tablet in 1 bottle, plastic | 69584-684-90 | Oxford Pharmaceuticals | 1 November 2026 |
| 9000 tablet in 1 bottle, plastic | 71610-540-09 | Aphena Pharma Solutions - Tennessee | 28 June 2021 |
| 90 tablet in 1 bottle, plastic | 71610-540-60 | Aphena Pharma Solutions - Tennessee | 6 April 2021 |
| 180 tablet in 1 bottle, plastic | 71610-540-80 | Aphena Pharma Solutions - Tennessee | 6 April 2021 |
| 270 tablet in 1 bottle, plastic | 71610-540-92 | Aphena Pharma Solutions - Tennessee | 6 April 2021 |
| 360 tablet in 1 bottle, plastic | 71610-540-94 | Aphena Pharma Solutions - Tennessee | 20 September 2021 |
| 90 tablet in 1 bottle, plastic | 71610-590-60 | Aphena Pharma Solutions - Tennessee | 9 August 2021 |
| 180 tablet in 1 bottle, plastic | 71610-590-80 | Aphena Pharma Solutions - Tennessee | 9 August 2021 |
| 270 tablet in 1 bottle, plastic | 71610-590-92 | Aphena Pharma Solutions - Tennessee | 9 August 2021 |
| 360 tablet in 1 bottle, plastic | 71610-590-94 | Aphena Pharma Solutions - Tennessee | 9 August 2021 |
| 90 tablet in 1 bottle | 71610-763-60 | Aphena Pharma Solutions - Tennessee | 9 January 2024 |
| 180 tablet in 1 bottle | 71610-763-80 | Aphena Pharma Solutions - Tennessee | 13 December 2023 |
| 270 tablet in 1 bottle | 71610-763-92 | Aphena Pharma Solutions - Tennessee | 13 December 2023 |
| 360 tablet in 1 bottle | 71610-763-94 | Aphena Pharma Solutions - Tennessee | 13 December 2023 |
| 30 tablet in 1 bottle | 63629-7811-1 | Bryant Ranch Prepack | 23 October 2018 |
| 90 tablet in 1 bottle | 63629-7811-2 | Bryant Ranch Prepack | 19 March 2019 |
| 60 tablet in 1 bottle | 63629-7811-3 | Bryant Ranch Prepack | 3 April 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 8 March 1954 | 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 Primidone 50 mg tablet.
Other strengths and forms of Primidone
Clinical summary
Primidone is an anti-epileptic agent indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It is available as tablets for oral use. MedsAcross supplies Primidone 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 PrimidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mysoline prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Primidone 50 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.