Medicine
Dilantin-125 125 mg/5 mL oral suspension
Dilantin-125 125 mg/5 mL oral suspension is a prescription medicine containing Phenytoin for oral use, marketed by Viatris Specialty, 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
Do not freeze. Store at 20° to 25°C (68° to 77°F), see USP controlled room…
Key facts
- Active ingredient (INN)
- Phenytoin
- Brand
- Dilantin-125
- Strength
- 125 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Viatris Specialty
- Manufacturer
- Viatris Specialty
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20° to 25°C (68° to 77°F), see USP controlled room temperature. Protect from light.
- 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
- 19 April 2024
- Identifiers
- RxCUI 1313112, 1313884DailyMed set ID f339f9e4-b289-4efe-82b9-46c57d1dc277NDC 58151-115Application NDA008762
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 |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 237 mL in 1 bottle, plastic | 58151-115-35 | Viatris Specialty | 19 April 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
Alternatives
Other makers and brands of Phenytoin 125 mg/5 mL oral suspension.
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 Dilantin-125 125 mg/5 mL oral suspension 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.