Medicine
Fosphenytoin 100 mg/2 mL injection
Fosphenytoin 100 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not…
Key facts
- Active ingredient (INN)
- Fosphenytoin
- Brand
- Sold under the generic name
- Strength
- 100 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 2 mL, 10 vials of 2 mL and 5 more
- Manufacturers
- Gland PharmaIndiaGlenmark PharmaceuticalsIndiaAmneal PharmaceuticalsFresenius KabiHikma PharmaceuticalsSagent PharmaceuticalsWest-Ward Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not be stored at room temperature for more than 48 hours.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AB05 Fosphenytoin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 August 2007
- Identifiers
- RxCUI 1670195, 1670200DailyMed set ID 519a44e3-8a93-456c-b71c-894513810d45, c92df63b-5140-4213-8d43-8327ff6230b7, 49b08648-6a83-42c7-ae7b-80c29f2534fc +4NDC 0641-6136, 0143-9788, 68083-460 +5Application ANDA077989, ANDA078765, ANDA214926 +2
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 |
|---|---|---|---|
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 68083-460-25 | Gland PharmaIndia | 13 October 2023 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 68462-621-54 | Glenmark PharmaceuticalsIndia | 13 October 2023 |
| 25 vial in 1 carton / 2 mL in 1 vial | 65162-998-25 | Amneal Pharmaceuticals | 17 May 2013 |
| 10 vial in 1 carton / 2 mL in 1 vial | 65162-999-10 | Amneal Pharmaceuticals | 17 May 2013 |
| 25 vial in 1 tray / 2 mL in 1 vial | 63323-403-02 | Fresenius Kabi | 14 December 2009 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0641-6136-25 | Hikma Pharmaceuticals | 6 August 2007 |
| 25 vial in 1 carton / 2 mL in 1 vial | 25021-798-02 | Sagent Pharmaceuticals | 15 January 2025 |
| 25 vial in 1 package / 2 mL in 1 vial | 0143-9788-25 | West-Ward Pharmaceuticals | 2 December 2009 |
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 5 August 1996 | 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 Fosphenytoin 100 mg/2 mL injection.
Other strengths and forms of Fosphenytoin
Clinical summary
Fosphenytoin is an anti-epileptic agent indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. It is available as injection for intramuscular and intravenous use. MedsAcross supplies Fosphenytoin 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 FosphenytoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CEREBYX prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Fosphenytoin 100 mg/2 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.