United States· US:0025-1451_882c6a95-ced5-4c8a-a72f-8ca5ed499a6d
Cytotec
A medicinal product containing misoprostol, registered in United States by Pfizer Laboratories Div Pfizer Inc.
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
- misoprostol
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Misoprostol in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaMISOPROSTOLAA PHARMA INC
- United KingdomApo-Misoprostol 100microgram tabletsImported (United States)
- NorwayMisoprostol aa pharmaAA Pharma
- CzechiaANGUSTANorgine B.V., Amsterdam
- PolandAngustaNorgine B.V.
- NetherlandsAngusta 25 microgram tablettenNorgine B.V.
- SpainANGUSTA 25 MICROGRAMOS COMPRIMIDOSNorgine B.V.
- BelgiumAngusta 25 µgNorgine
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Angusta®, Cyprostol
- Belgium · Angusta, Cytotec
- Bulgaria · Ангуста, Топогин
- Cyprus · Angusta, Misoone
- Czechia · Angusta, Mispregnol
- Germany · Angusta, Misoone
- Denmark · Angusta, Cytotec
- Estonia · Angusta, Gyxiny
- Spain · Angusta, Cytotec
- Finland · Angusta, Cytotec
- France · Angusta, Gymiso
- United Kingdom (Northern Ireland) · Angusta, Cytotec
- Greece · Angusta, Cytotec
- Croatia · Angusta, Mispregnol
- Hungary · Angusta
- Ireland · Angusta, Cytotec
- Iceland · Angusta, Cytotec
- Italy · Angusta, Cytotec
- Lithuania · Gyxiny, Misoone
- Luxembourg · Angusta, Cytotec
- Latvia · Angusta, Gyxiny
- Malta · Angusta
- Netherlands · Angusta, Cytotec
- Norway · Angusta, Cytotec
- Poland · Angusta, Cytotec
- Portugal · Angusta, Cytotec
- Romania · Angusta, Topogyne
- Sweden · Angusta, Cytotec
- Slovenia · Angusta, Topogyne
- Slovakia · Angusta
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/fab90980-3f2a-452e-9fd5-df7bca440839 GET /v1/drugs/fab90980-3f2a-452e-9fd5-df7bca440839?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",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 5
},
"productid": "0025-1451_882c6a95-ced5-4c8a-a72f-8ca5ed499a6d",
"productndc": "0025-1451",
"dosage_form": "TABLET",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MISOPROSTOL",
"proprietary_name": "Cytotec",
"active_ingred_unit": "ug/1",
"application_number": "NDA019268",
"marketing_category": "NDA",
"nonproprietary_name": "misoprostol",
"start_marketing_date": "19861227",
"active_numerator_strength": "100"
}See everything about misoprostol.
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.