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United States· US:63629-8626_2b0ef1d5-1e1a-4d7f-bd04-11bb48f04e0f

Ciclopirox olamine

A other antifungals for topical use product containing ciclopirox olamine, registered in United States by Bryant Ranch Prepack.

ATC D01AEOrange BookUS 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…normalisedCiclopirox olamineATCD01AEREGISTER NO.US:63629-8626_2b0ef1d…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ciclopirox olamineAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Ciclopirox olamine
Manufacturer
Bryant Ranch Prepack
Country
United States (US)
ATC code
D01AE
ATC class
Other antifungals for topical use
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    6362986261
    1 TUBE in 1 CARTON (63629-8626-1) / 90 g in 1 TUBE

Regulatory notes

UNII (FDA substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A077364
AB
DailyMed SPL labels
1 version tracked

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.

All ciclopirox olamine products

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/ad6928a8-43b6-43f9-a7a4-8d1f22d6d005
GET /v1/drugs/ad6928a8-43b6-43f9-a7a4-8d1f22d6d005?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.

{
  "unii": {
    "unii": "50MD4SB4AP",
    "rxcui": "52172",
    "inchikey": "MBRHNTMUYWQHMR-UHFFFAOYSA-N",
    "display_name": "CICLOPIROX OLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "1a74ed86-997a-4b86-b54a-b2b2c94e8abb": {
      "match": "brand_token",
      "title": "CICLOPIROX OLAMINE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
      "spl_version": "14",
      "published_date": "2026-04-17"
    }
  },
  "productid": "63629-8626_2b0ef1d5-1e1a-4d7f-bd04-11bb48f04e0f",
  "productndc": "63629-8626",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "077364",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Mar 3, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX OLAMINE",
  "proprietary_name": "Ciclopirox olamine",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA077364",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciclopirox olamine",
  "start_marketing_date": "20060719",
  "active_numerator_strength": "7.7"
}
API referenceMCP serverPlans

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.

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