Medicine
Phenytoin 250 mg/5 mL injection
Phenytoin 250 mg/5 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 4 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°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
Key facts
- Active ingredient (INN)
- Phenytoin
- Brand
- Sold under the generic name
- Strength
- 250 mg/5 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 5 mL, 25 vials of 5 mL, 5 mL and 4 more
- Manufacturers
- Hikma PharmaceuticalsAcella PharmaceuticalsHealthFirstHenry Schein
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
- 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 July 1975
- Identifiers
- RxCUI 1670351, 1670353DailyMed set ID a52cf1bd-dc1f-47be-aba8-29066d9a50fb, 035a8d4e-2063-4240-83cb-d7eebcabe301, 8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7 +2NDC 0404-9808, 0641-2555, 0641-6139 +2Application ANDA084307, ANDA040573
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 |
|---|---|---|---|
| 10 vial in 1 carton / 5 mL in 1 vial | 0641-2555-10 | Hikma Pharmaceuticals | 21 September 2023 |
| 25 vial in 1 carton / 5 mL in 1 vial | 0641-2555-45 | Hikma Pharmaceuticals | 16 July 1975 |
| 10 vial in 1 carton / 5 mL in 1 vial | 0641-6139-10 | Hikma Pharmaceuticals | 22 September 2023 |
| 25 vial in 1 carton / 5 mL in 1 vial | 0641-6139-25 | Hikma Pharmaceuticals | 16 July 1975 |
| 10 vial in 1 carton / 5 mL in 1 vial | 42192-614-30 | Acella Pharmaceuticals | 30 December 2021 |
| 5 mL in 1 vial, single-dose | 51662-1250-1 | HealthFirst | 19 September 2018 |
| 1 vial in 1 bag / 5 mL in 1 vial | 0404-9808-05 | Henry Schein | 26 December 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 250 mg/5 mL injection 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.