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United States· US:0245-0575_51287574-9a83-45db-9b8d-cc8bcb8a44db

Isotretinoin

A isotretinoin product containing isotretinoin, registered in United States by Upsher-Smith Laboratories, LLC. The same ATC class is registered in 3 of our 19 countries.

ATC IsotretinoinUS 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…normalisedIsotretinoinATCIsotretinoinREGISTER NO.US:0245-0575_51287574…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about isotretinoinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Isotretinoin is registered in 3 of 19 countries.

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

  • This record: United States, from FDA National Drug Code directory (United States)
  • 1 of them publish a price we can compare per daily dose
Search isotretinoin products by name

Isotretinoin · ATC Isotretinoin

3 / 19 countries

  • Germany
  • 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
ISOTRETINOIN
Manufacturer
Upsher-Smith Laboratories, LLC
Country
United States (US)
ATC code
Isotretinoin
ATC class
Isotretinoin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0245057501
    3 BLISTER PACK in 1 BOX (0245-0575-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89)
  • ndc11
    0245-0575-01

Regulatory notes

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

Same medicine, other countries

Isotretinoin in 17 other countries

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

All isotretinoin products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Aknenormin®, Ciscutan
  • Belgium · Isocural, Isosupra Lidose
  • Bulgaria · Роакутан
  • Cyprus · Acmotren, Isotroin
  • Czechia · Aknenormin, Asotiorga
  • Germany · Aknenormin, Isogalen
  • Denmark · Acnenor, Isomacne
  • Estonia · Isotiorga, Isotretinoin Sandoz
  • Spain · Acnemin 10 Mg, Acnemin 20 Mg
  • Finland · Isotretinoin Actavis, Isotretinoin Orifarm
  • France · Acnetrait, Contracne
  • United Kingdom (Northern Ireland) · Isotretinoin Ennogen Ip, Isotretinoin Sun Pharmaceutical Industries Europe
  • Greece · A-Cnotren, Acnesyn
  • Croatia · Roaccutane
  • Hungary · Inerta, Isotiorga
  • Ireland · Isotretinoin Gap, Isotretinoin Rowex
  • Iceland · Decutan
  • Italy · Aisoskin, Isdiben
  • Lithuania · Isotretinoin Sandoz, Roaccutane
  • Luxembourg · Isotiorga, Roaccutane
  • Latvia · Isotretinoin Sandoz, Roaccutane
  • Malta · Contracne, Isotretinoin
  • Netherlands · Isotretinoine Aurobindo, Isotretinoïne Doc
  • Norway · Isotretinoin Orifarm, Isotretinoin Sandoz
  • Poland · Aknenormin, Axotret
  • Portugal · Isotiorga, Isotretinoína Aurovitas
  • Romania · Isotiorga, Roaccutane
  • Sweden · Isotracin, Isotretinoin Actavis
  • Slovenia · Retitren
  • Slovakia · Aknenormin 10, Aknenormin 20

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/d215604d-a349-49da-b37c-2fd27763cecd
GET /v1/drugs/d215604d-a349-49da-b37c-2fd27763cecd?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": "ORAL",
  "source": "ndc",
  "strength": "40",
  "substance": "ISOTRETINOIN",
  "productndc": "0245-0575",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA213571",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about isotretinoin.

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