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United States· US:68083-460_00f57b3c-3819-440e-a928-eeec0fee27aa

Fosphenytoin sodium

A fosphenytoin product containing fosphenytoin sodium, registered in United States by Gland Pharma Limited. The same ATC class is registered in 11 of our 19 countries.

ATC N03AB05US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedFosphenytoin sodiumATCN03AB05REGISTER NO.US:68083-460_00f57b3c…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about fosphenytoin sodiumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search fosphenytoin products by name

Fosphenytoin · ATC N03AB05

11 / 19 countries

  • Canada
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Norwayprice
  • Sweden
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FOSPHENYTOIN SODIUM
Manufacturer
Gland Pharma Limited
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

  • ndc11
    68083-460-25
  • ndc11
    6808346025
    25 VIAL, SINGLE-DOSE in 1 CARTON (68083-460-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01)

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
Check fosphenytoin against other medicinesHow interaction checks work

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All fosphenytoin products

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/a861a8b0-10fa-4f34-b5da-0efbe5b73dc5
GET /v1/drugs/a861a8b0-10fa-4f34-b5da-0efbe5b73dc5?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": "68083-460",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA214926",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console