United States· US:10129-006_552f7c53-4da9-8ebd-e063-6394a90a5632

Orostat 8%

A medicinal product containing epinephrine hydrochloride, registered in United States by Gingi-Pak a Division of the Belport.

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedOrostat 8%ATC—REGISTER NO.US:10129-006_552f7c53…PACKS LISTED1CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
EPINEPHRINE HYDROCHLORIDE
Manufacturer
Gingi-Pak a Division of the Belport
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 1

  • ndc11
    10129-006-02

Regulatory notes

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

Same medicine, other countries

Epinephrine hydrochloride in 13 other countries

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

All epinephrine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Adrenalin Aguettant, Adrenalin Noridem
  • Belgium · Adrenaline (Tartrate) Aguettant, Adrenaline (Tartrate) Bradex
  • Bulgaria · Адреналин Софарма, Епипен Н
  • Cyprus · Anapen, Anapen Junior
  • Czechia · Adrenalin Bradex, Adrenalin Léčiva
  • Germany · Adrenalin Aguettant, Adrenalin Ethypharm
  • Denmark · Adrenalin Aguettant, Adrenalin Bradex
  • Estonia · Adrenaline Auxilia, Epipen
  • Spain · Adrenalina Aguettant, Adrenalina B. Braun
  • Finland · Adrenalin Aguettant, Adrenalin Ethypharm
  • France · Adrenaline Accord, Adrenaline Aguettant
  • United Kingdom (Northern Ireland) · Adrenaline (Epinephrine) Aurum Pharmaceuticals, Adrenaline (Epinephrine) For Anaphylaxis Aurum Pharmaceuticals
  • Greece · Adrenaline Injection Ariti, Anapen
  • Croatia · Epipen, Epipen Jr.
  • Hungary · Adrenalin Bradex, Adresalf
  • Ireland · Adrenaline (Epinephrine) Laboratoire Aguettant, Adrenaline (Epinephrine) Mercury Pharmaceuticals (Ireland)
  • Iceland · Adrenalin Viatris, Epipen
  • Italy · Adrenalina Aguettant, Adrenalina Galenica Senese
  • Liechtenstein · Eurneffy
  • Lithuania · Epipen, Epixust
  • Luxembourg · Adrenaline (Tartrate) Aguettant, Adrenaline Bradex
  • Latvia · Adrenaline Sopharma, Epipen
  • Malta · Adrenalin Martindale Pharma, Adrenaline (Epinephrine) Mercury Pharmaceuticals (Ireland)
  • Netherlands · Adrenaline Accord, Adrenaline Aguettant
  • Norway · Adrenalin Aguettant, Adrenalin Ethypharm
  • Poland · Adrenalina Aguettant, Adrenalina Noridem
  • Portugal · Adrenalina Accord, Adrenalina Aguettant
  • Romania · Adrenalina Hypericum, Adrenalină Noridem
  • Sweden · Adrenalin Aguettant, Adrenalin Bradex
  • Slovenia · Anapen, Anapen Za Otroke
  • Slovakia · Adrenalin Bradex, Adrenalin Léčiva

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/f9323bc5-cb6c-4cf5-8a36-53f61ffe568f
GET /v1/drugs/f9323bc5-cb6c-4cf5-8a36-53f61ffe568f?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": "DENTAL; PERIODONTAL; SUBGINGIVAL",
  "source": "ndc",
  "strength": "1200",
  "substance": "EPINEPHRINE HYDROCHLORIDE",
  "productndc": "10129-006",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/15mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER"
}

See everything about epinephrine hydrochloride.

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.