Medicine
Phenytek 200 mg extended-release capsule
Phenytek 200 mg extended-release capsule is a prescription medicine containing Phenytoin for oral use, marketed by Mylan Pharmaceuticals, 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 light and moisture.
Key facts
- Active ingredient (INN)
- Phenytoin
- Brand
- Phenytek
- Strength
- 200 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules
- Marketing authorisation holder
- Mylan Pharmaceuticals
- Manufacturers
- Mylan PharmaceuticalsCoupler
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light and 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
- 10 December 2001
- Identifiers
- RxCUI 855861, 855863, 855873 +1DailyMed set ID 0f94c791-8b07-4b41-927e-c9f28bec5f60, 2cdc1905-8f45-1275-e063-6394a90a2ab7NDC 0378-2670, 67046-1486Application ANDA040298
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule, extended release in 1 bottle | 0378-2670-01 | Mylan Pharmaceuticals | 10 December 2001 |
| 30 capsule, extended release in 1 bottle | 0378-2670-93 | Mylan Pharmaceuticals | 10 December 2001 |
| 30 capsule, extended release in 1 blister pack | 67046-1486-3 | Coupler | 29 January 2025 |
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 200 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 Phenytek 200 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.