Medicine
Cerebyx 500 mg/10 mL injection
Cerebyx 500 mg/10 mL injection is a prescription medicine containing Fosphenytoin for intramuscular, intravenous use, marketed by Pfizer Laboratories, 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
- Cerebyx
- Strength
- 500 mg/10 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 10 mL
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturer
- Pfizer Laboratories
- 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
- 28 October 2013
- Identifiers
- RxCUI 1670195, 1670197, 1670200 +1DailyMed set ID d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a, de5a6711-4abb-4c3d-a18b-266b094ace11NDC 0069-6001, 0069-5474Application NDA020450
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 package / 10 mL in 1 vial, single-dose | 0069-5474-02 | Pfizer Laboratories | 28 October 2013 |
| 10 vial in 1 package / 10 mL in 1 vial | 0069-6001-21 | Pfizer Laboratories | 28 October 2013 |
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 500 mg/10 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 Cerebyx 500 mg/10 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.