United States· US:72189-278_2c290c08-d35f-21b4-e063-6394a90a73b9
NYSTATIN
A medicinal product containing nystatin, registered in United States by DIRECT RX.
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
- NYSTATIN
- Manufacturer
- DIRECT RX
- 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 · 2
- ndc11721892781515 g in 1 BOX (72189-278-15)
- ndc1172189-278-15
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nystatin in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- GermanyAdiclairArdeypharm Gmbh
- United KingdomNystamont 100,000units/ml oral suspensionRosemont Pharmaceuticals Ltd
- NorwayBiofanalPfleger
- CanadaJAMP-NYSTATIN ORAL SUSPENSION USPJAMP PHARMA CORPORATION
- SwedenNystatin Ebb 100000 IE/ml Oral suspensionEbb Medical AB
- PolandNyscandinAflofarm Farmacja Polska Sp. z o.o.
- FinlandMycostatinBristol-Myers Squibb Ab
- NetherlandsNystatine ERC 100.000 E/ml, suspensie voor oraal gebruikEuro Registratie Collectief B.V.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Candio, Mycostatin
- Belgium · Nilstat, Skandyra
- Bulgaria · Нистатин Абр, Нистатин Актавис
- Cyprus · Nystamysyn, Restatin
- Czechia · Fungicidin Léčiva
- Germany · Adiclair, Biofanal
- Denmark · Nystatin Orifarm, Nystimex
- Spain · Mycostatin
- Finland · Nystatin Orifarm, Nystimex
- France · Mycostatine
- United Kingdom (Northern Ireland) · Nystan, Nystatin Vygoris
- Greece · Nystamysyn
- Croatia · Pronigyn
- Hungary · Nystatin Pannonpharma
- Ireland · Mycostatin (Ready Mixed)
- Iceland · Nystatin Orifarm, Nystimex
- Italy · Mycostatin
- Lithuania · Nystatin Actavis
- Luxembourg · Biofanal Kombi, Candio-Hermal
- Netherlands · Nystatine Labaz, Nystatine Rph
- Norway · Nystatin Orifarm, Nystimex
- Poland · Nyscandin, Nystapol
- Portugal · Mycostatin
- Romania · Nistatina Atb, Nistatină Atb
- Sweden · Nystatin Evolan, Nystatin Orifarm
- Slovenia · Pronigyn
- Slovakia · Fungicidin Léčiva, Nystatin Galvex
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/ab63e74b-67c5-4df0-a508-3a04abd50050 GET /v1/drugs/ab63e74b-67c5-4df0-a508-3a04abd50050?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; TOPICAL",
"source": "ndc",
"strength": "100000",
"substance": "NYSTATIN",
"productndc": "72189-278",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "[USP'U]/g",
"application_number": "ANDA064022",
"marketing_category": "ANDA"
}See everything about nystatin.
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.