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United States· US:70069-008_a873a505-bb9c-4430-8921-8d800df991c7

EPINASTINE HYDROCHLORIDE

A epinastine product containing epinastine hydrochloride, registered in United States by Somerset Therapeutics, LLC. The same ATC class is registered in 8 of our 19 countries.

ATC S01GX10US 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…normalisedEPINASTINE HYDROCHLORIDEATCS01GX10REGISTER NO.US:70069-008_a873a505…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Epinastine is registered in 8 of 19 countries.

Countries holding a registration under ATC S01GX10 (epinastine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 5 of them publish a price we can compare per daily dose

Epinastine · ATC S01GX10

8 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Ireland
  • Netherlands
  • Polandprice
  • 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
EPINASTINE HYDROCHLORIDE
Manufacturer
Somerset Therapeutics, LLC
Country
United States (US)
ATC code
S01GX10
ATC class
Epinastine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    7006900801
    1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE
  • ndc11
    70069-008-01

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Epinastine in 11 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All epinastine products

Authorised across Europe · EMA

The same active substance is authorised in 13 EEA countries. Names it is sold under:

  • Belgium · Relestat
  • Czechia · Purivist
  • France · Purivist
  • United Kingdom (Northern Ireland) · Relestat
  • Greece · Optallerg, Relestat
  • Hungary · Relestat
  • Ireland · Relestat
  • Italy · Relestat
  • Luxembourg · Relestat
  • Netherlands · Relestat
  • Portugal · Relestat
  • Sweden · Relestat
  • Slovakia · Purivist

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/b1fd2303-e2ed-4cf4-8ea5-7ea28dccfc0e
GET /v1/drugs/b1fd2303-e2ed-4cf4-8ea5-7ea28dccfc0e?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": "OPHTHALMIC",
  "source": "ndc",
  "strength": ".5",
  "substance": "EPINASTINE HYDROCHLORIDE",
  "productndc": "70069-008",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA090951",
  "marketing_category": "ANDA"
}

See everything about epinastine.

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.