Medicine
Primidone 125 mg tablet
Primidone 125 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 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
- 125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 100 tablets, 500 tablets and 4 more
- Manufacturers
- Advagen PharmaTruPharma
- 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
- 28 June 2022
- Identifiers
- RxCUI 328176, 96304, 198150DailyMed set ID c60b3a92-4404-4a89-b2c5-c23ff72bedad, b3b94d2e-6a64-45b7-b0cb-0fde689240d8NDC 52817-117, 72888-160Application ANDA214896
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 |
|---|---|---|---|
| 1000 tablet in 1 bottle | 72888-160-00 | Advagen Pharma | 28 June 2022 |
| 100 tablet in 1 bottle | 72888-160-01 | Advagen Pharma | 28 June 2022 |
| 500 tablet in 1 bottle | 72888-160-05 | Advagen Pharma | 28 June 2022 |
| 30 tablet in 1 bottle | 72888-160-30 | Advagen Pharma | 28 June 2022 |
| 100 tablet in 1 bottle | 52817-117-10 | TruPharma | 21 February 2023 |
| 30 tablet in 1 bottle | 52817-117-30 | TruPharma | 21 February 2023 |
| 500 tablet in 1 bottle | 52817-117-50 | TruPharma | 21 February 2023 |
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
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 125 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.