United States· US:45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8
gynazole 1
A butoconazole product containing butoconazole nitrate, registered in United States by Padagis Israel Pharmaceuticals Ltd. The same ATC class is registered in 3 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Butoconazole is registered in 3 of 19 countries.
Countries holding a registration under ATC G01AF15 (butoconazole), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 3 of them publish a price we can compare per daily dose
Butoconazole · ATC G01AF15
3 / 19 countries
- Belgiumprice
- Polandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BUTOCONAZOLE NITRATE
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Country
- United States (US)
- ATC code
- G01AF15
- ATC class
- Butoconazole
- Defined daily dose
- 0.1 g, V
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1145802-396-01
- ndc1145802-396-02
- ndc1145802396011 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR
- ndc1145802396021 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Butoconazole in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Bulgaria · Gynazol
- Hungary · Gynazol
- Poland · Gynazol
- Romania · Gynofort
- Slovakia · Gynazol
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/6ce29069-a59a-490b-a7e6-82d01794b2ca GET /v1/drugs/6ce29069-a59a-490b-a7e6-82d01794b2ca?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": "VAGINAL",
"source": "ndc",
"strength": "100",
"substance": "BUTOCONAZOLE NITRATE",
"productndc": "45802-396",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "mg/5g",
"application_number": "ANDA200923",
"marketing_category": "ANDA"
}See everything about butoconazole.
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.