Medicine
Phenytoin 100 mg extended-release capsule
Phenytoin 100 mg extended-release capsule is a generic prescription medicine for oral use, made by 10 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
- 100 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 30 capsules and 22 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaUnichem LaboratoriesIndiaAphena Pharma Solutions - TennesseeA-S Medication SolutionsRemedyrepackGolden State Medical SupplyAvPAKCouplerMajor PharmaceuticalsProficient Rx
- 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
- 5 September 2006
- Identifiers
- RxCUI 855671DailyMed set ID 601f7353-225d-4a5d-9810-3869c2c21874, 29b8d0a2-a96e-46a5-e063-6394a90a7113, 51b660c3-7d88-77b2-e063-6294a90a0286 +10NDC 51672-4111, 71610-869, 67046-0585 +10Application ANDA040684, ANDA213834
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 capsule, extended release in 1 bottle | 51672-4111-1 | Sun Pharmaceutical IndustriesIndia | 5 September 2006 |
| 1000 capsule, extended release in 1 bottle | 51672-4111-3 | Sun Pharmaceutical IndustriesIndia | 5 September 2006 |
| 30 capsule, extended release in 1 bottle | 51672-4111-6 | Sun Pharmaceutical IndustriesIndia | 5 September 2006 |
| 100 capsule, extended release in 1 bottle | 29300-379-01 | Unichem LaboratoriesIndia | 12 November 2022 |
| 500 capsule, extended release in 1 bottle | 29300-379-05 | Unichem LaboratoriesIndia | 12 November 2022 |
| 1000 capsule, extended release in 1 bottle | 29300-379-10 | Unichem LaboratoriesIndia | 12 November 2022 |
| 100 capsule, extended release in 1 bottle | 50090-3539-0 | A-S Medication Solutions | 15 August 2018 |
| 90 capsule, extended release in 1 bottle | 50090-3539-1 | A-S Medication Solutions | 15 August 2018 |
| 100 capsule, extended release in 1 bottle | 50090-5700-0 | A-S Medication Solutions | 23 September 2021 |
| 90 capsule, extended release in 1 bottle | 50090-5700-1 | A-S Medication Solutions | 24 September 2021 |
| 270 capsule, extended release in 1 bottle | 71610-869-92 | Aphena Pharma Solutions - Tennessee | 11 December 2024 |
| 360 capsule, extended release in 1 bottle | 71610-869-94 | Aphena Pharma Solutions - Tennessee | 11 December 2024 |
| 540 capsule, extended release in 1 bottle | 71610-869-98 | Aphena Pharma Solutions - Tennessee | 11 December 2024 |
| 270 capsule, extended release in 1 bottle | 71610-934-92 | Aphena Pharma Solutions - Tennessee | 2 September 2025 |
| 360 capsule, extended release in 1 bottle | 71610-934-94 | Aphena Pharma Solutions - Tennessee | 6 August 2025 |
| 540 capsule, extended release in 1 bottle | 71610-934-98 | Aphena Pharma Solutions - Tennessee | 18 August 2025 |
| 30 capsule, extended release in 1 blister pack | 70518-0107-0 | Remedyrepack | 6 January 2017 |
| 30 capsule, extended release in 1 blister pack | 70518-2293-0 | Remedyrepack | 3 September 2019 |
| 100 pouch in 1 box / 1 capsule, extended release in 1 pouch | 70518-2293-1 | Remedyrepack | 5 August 2021 |
| 30 blister pack in 1 carton / 1 capsule, extended release in 1 blister pack | 50268-719-13 | AvPAK | 3 March 2026 |
| 30 capsule, extended release in 1 blister pack | 67046-0585-3 | Coupler | 13 May 2026 |
| 100 capsule, extended release in 1 bottle | 51407-982-01 | Golden State Medical Supply | 7 May 2025 |
| 1000 capsule, extended release in 1 bottle | 51407-982-10 | Golden State Medical Supply | 7 May 2025 |
| 100 blister pack in 1 carton / 1 capsule, extended release in 1 blister pack | 0904-7416-61 | Major Pharmaceuticals | 9 December 2025 |
| 120 capsule, extended release in 1 bottle | 82804-269-72 | Proficient Rx | 26 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 100 mg extended-release capsule.
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 100 mg extended-release capsule 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.