Medicine
Phenytoin 100 mg capsule
Phenytoin 100 mg capsule is a generic prescription medicine for oral use, made by 7 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 o to 25 • C (68 o to 77 • F). Protect from moisture.
Key facts
- Active ingredient (INN)
- Phenytoin
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 10 blister pack, 1000 capsules and 12 more
- Manufacturers
- Aurobindo PharmaIndiaAmneal PharmaceuticalsDirect_RxBryant Ranch PrepackAmerican Health PackagingRemedyrepackVangard Labs
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o 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
- 16 December 2009
- Identifiers
- RxCUI 855671DailyMed set ID 7e467c02-49a0-4b62-b537-430fdfa4f10e, a9a1059e-63a2-486e-aa50-eda388f79525, 5b64cb11-673a-41ec-9b2a-1e194ae5eb0c +4NDC 65162-212, 72162-2514, 60687-841 +4Application ANDA040765, ANDA204309
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 in 1 bottle | 65862-692-01 | Aurobindo PharmaIndia | 10 June 2015 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 65862-692-78 | Aurobindo PharmaIndia | 10 June 2015 |
| 1000 capsule in 1 bottle | 65862-692-99 | Aurobindo PharmaIndia | 10 June 2015 |
| 30 capsule in 1 bottle | 65162-212-03 | Amneal Pharmaceuticals | 16 December 2009 |
| 100 capsule in 1 bottle | 65162-212-10 | Amneal Pharmaceuticals | 16 December 2009 |
| 1000 capsule in 1 bottle | 65162-212-11 | Amneal Pharmaceuticals | 16 December 2009 |
| 500 capsule in 1 bottle | 65162-212-50 | Amneal Pharmaceuticals | 16 December 2009 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 60687-841-01 | American Health Packaging | 6 February 2025 |
| 1000 capsule in 1 bottle | 72162-2514-0 | Bryant Ranch Prepack | 9 June 2025 |
| 100 capsule in 1 bottle | 72162-2514-1 | Bryant Ranch Prepack | 9 June 2025 |
| 30 capsule in 1 bottle | 61919-815-30 | Direct RX | 1 January 2014 |
| 100 capsule in 1 bottle | 61919-815-71 | Direct RX | 1 January 2014 |
| 120 capsule in 1 bottle | 61919-815-72 | Direct RX | 1 January 2014 |
| 30 capsule in 1 blister pack | 70518-2227-3 | Remedyrepack | 29 June 2024 |
| 30 capsule in 1 blister pack | 0615-8556-39 | Vangard Labs | 16 October 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 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
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 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.