United States· US:45802-138_adbf1f16-8243-4280-86b2-fd3dc41af5b0
Ciclopirox olamine
A medicinal product containing ciclopirox olamine, registered in United States by Padagis Israel Pharmaceuticals Ltd.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- CICLOPIROX OLAMINE
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 2, 2026
Packs & prices · 6
- ndc1145802138111 TUBE in 1 CARTON (45802-138-11) / 30 g in 1 TUBE
- ndc1145802138181 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE
- ndc1145802138351 TUBE in 1 CARTON (45802-138-35) / 15 g in 1 TUBE
- ndc1145802-138-11
- ndc1145802-138-18
- ndc1145802-138-35
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ciclopirox olamine in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceCICLOPIROX OLAMINE ARROW 1,5 %, shampooingARROW GENERIQUES
- GermanyBatrafenZentiva Pharma Gmbh
- CzechiaBATRAFENZentiva, k.s., Praha
- BelgiumCiclopirox Olamine Polichem 10 mg/mlPolichem
- CanadaLOPROXBAUSCH HEALTH, CANADA INC.
- IrelandStieprox 15 mg/g ShampooGlaxoSmithKline (Ireland) Limited
- FinlandSebiproxGlaxoSmithKline Oy
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Cyprus · Mycomycen
- Czechia · Batrafen, Dafnegin
- Germany · Batrafen, Ciclocutan
- Spain · Capitec, Ciclochem
- France · Ciclopirox Olamine Arrow, Ciclopirox Olamine Biogaran
- Greece · Mycomycen, Neo-Botacreme
- Croatia · Oxolam
- Hungary · Batrafen
- Ireland · Stieprox
- Italy · Bioginal, Dafnegin
- Luxembourg · Mycoster
- Malta · Mycoskin
- Netherlands · Loprox
- Poland · Ciclopirox Ziaja, Dafnegin
- Portugal · Mycoster
- Slovakia · Batrafen
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/529ed2a6-8c77-4452-9308-04b9eb052abc GET /v1/drugs/529ed2a6-8c77-4452-9308-04b9eb052abc?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": "TOPICAL",
"source": "ndc",
"strength": "7.7",
"substance": "CICLOPIROX OLAMINE",
"productndc": "45802-138",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "mg/g",
"application_number": "ANDA077364",
"marketing_category": "ANDA"
}See everything about ciclopirox olamine.
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.