Medicine
Phenytoin 50 mg chewable tablet
Phenytoin 50 mg chewable tablet is a generic prescription medicine for oral use, made by 6 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). Protect from moisture.
Key facts
- Active ingredient (INN)
- Phenytoin
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Chewable tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 6 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaRemedyrepackAmerican Health PackagingMajor PharmaceuticalsRising Pharma HoldingsVangard Labs
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AB02 Phenytoin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 April 2014
- Identifiers
- RxCUI 1313885DailyMed set ID 98bd1d9f-b1a4-49eb-a0b4-a790265710dd, e95cad66-b5f9-4802-a35f-fed340bf09ab, 78b38e7b-1460-4adc-b738-320ffa6259c2 +3NDC 0615-8623, 64980-573, 51672-4146 +3Application ANDA200565, ANDA200691
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, chewable in 1 bottle | 51672-4146-1 | Sun Pharmaceutical IndustriesIndia | 17 April 2014 |
| 1000 tablet, chewable in 1 bottle | 51672-4146-3 | Sun Pharmaceutical IndustriesIndia | 17 April 2014 |
| 30 tablet, chewable in 1 bottle | 51672-4146-6 | Sun Pharmaceutical IndustriesIndia | 17 April 2014 |
| 100 tablet, chewable in 1 bottle | 64980-573-01 | Rising Pharma Holdings | 3 May 2024 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, chewable in 1 blister pack | 60687-156-25 | American Health Packaging | 2 December 2015 |
| 30 blister pack in 1 carton / 1 tablet, chewable in 1 blister pack | 0904-7199-07 | Major Pharmaceuticals | 17 April 2014 |
| 30 tablet, chewable in 1 blister pack | 70518-0841-0 | Remedyrepack | 10 November 2017 |
| 50 pouch in 1 box / 1 tablet, chewable in 1 pouch | 70518-0841-3 | Remedyrepack | 25 April 2026 |
| 30 tablet, chewable in 1 blister pack | 0615-8623-39 | Vangard Labs | 10 February 2026 |
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 6 January 1953 | 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 Phenytoin 50 mg chewable tablet.
Other strengths and forms of Phenytoin
Clinical summary
Phenytoin is an anti-epileptic agent indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. It is available as extended-release capsules, injection and chewable tablets for oral, intramuscular and intravenous use. MedsAcross supplies Phenytoin 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 PhenytoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Phenytoin prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Phenytoin 50 mg chewable 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.