United States· US:0641-6136_d276be92-654c-4912-8dc5-3e148c835523
Fosphenytoin Sodium
A fosphenytoin product containing fosphenytoin sodium, registered in United States by Hikma Pharmaceuticals USA Inc.. The same ATC class is registered in 11 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Fosphenytoin is registered in 11 of 19 countries.
Countries holding a registration under ATC N03AB05 (fosphenytoin), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 4 of them publish a price we can compare per daily dose
Fosphenytoin · ATC N03AB05
11 / 19 countries
- Canada
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Japan
- Norwayprice
- Sweden
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- FOSPHENYTOIN SODIUM
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Country
- United States (US)
- ATC code
- N03AB05
- ATC class
- Fosphenytoin
- Defined daily dose
- 0.45 g, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc11064161362525 VIAL in 1 CARTON (0641-6136-25) / 2 mL in 1 VIAL (0641-6136-01)
- ndc110641-6136-25
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
430 interactions on record for fosphenytoin.
Graded by severity as the source publishes them — 128 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Fosphenytoin · interactions on record
430 records
- 128 severe
- 275 moderate
- 10 minor
- 17 info
Most severe, free to view
- CimetidineA02BA01severe
- RolapitantA04AD14severe
- NaloxegolA06AH03severe
- NaldemedineA06AH05severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Fosphenytoin in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenFosphenytoin Eugia 75 mg/ml (50 mg FE/ml) Koncentrat till injektions-/infusionsvätska, lösningEugia Pharma (Malta) Limited
- GermanyFosphenytoin DesitinDesitin Arzneimittel Gmbh
- United KingdomPro-Epanutin 750mg/10ml concentrate for solution for injection vialsPfizer Ltd
- CanadaCEREBYXSEARCHLIGHT PHARMA INC
- IcelandPro-EpanutinPfizer ApS
- NorwayPro-EpanutinPfizer AS
- IrelandPro-Epanutin 75 mg/ml concentrate for solution for infusion/solution for injectionPfizer Healthcare Ireland Unlimited Company
- FinlandPro-EpanutinPfizer Oy
Authorised across Europe · EMA
The same active substance is authorised in 9 EEA countries. Names it is sold under:
- Germany · Fosphenytoin Desitin
- Denmark · Pro-Epanutin
- Finland · Pro-Epanutin
- France · Fosphenytoine Arrow, Prodilantin
- United Kingdom (Northern Ireland) · Pro-Epanutin
- Ireland · Pro-Epanutin
- Iceland · Pro-Epanutin
- Norway · Pro-Epanutin
- Sweden · Fosphenytoin Eugia, Fosphenytoin Frost
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ba3d20cd-08f5-4660-bb37-49fde9af6566 GET /v1/drugs/ba3d20cd-08f5-4660-bb37-49fde9af6566?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "50",
"substance": "FOSPHENYTOIN SODIUM",
"productndc": "0641-6136",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA077989",
"marketing_category": "ANDA"
}See everything about fosphenytoin.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.