United States· US:54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb
Misoprostol
A medicinal product containing misoprostol, registered in United States by PharmPak, 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
- PharmPak, 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 27, 2026
Packs & prices · 16
- ndc1154348-148-00
- ndc1154348-148-01
- ndc1154348-148-02
- ndc1154348-148-03
- ndc1154348-148-04
- ndc1154348-148-06
- ndc1154348-148-08
- ndc1154348-148-09
- ndc1154348148001 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE
- ndc1154348148011 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE
- ndc1154348148021 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE
- ndc1154348148031 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE
- ndc1154348148041 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE
- ndc1154348148061 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE
- ndc1154348148081 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE
- ndc1154348148091 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE
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.
- PolandCytotecDelfarma Sp. z o.o.
- United KingdomCytotec 200microgram tabletsWaymade Healthcare Plc
- NetherlandsCytotec 200 microgram, tablettenEuro Registratie Collectief B.V.
- NorwayCytotecPfizer
- SwitzerlandCytotec
- IcelandCytotecPfizer ApS
- SpainCYTOTEC 200 MICROGRAMOS COMPRIMIDOSPfizer S.L.
- FinlandCytotecPfizer Oy
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/f0366f3a-1dca-4b13-9d18-4ba8390c970d GET /v1/drugs/f0366f3a-1dca-4b13-9d18-4ba8390c970d?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",
"source": "ndc",
"strength": "200",
"substance": "MISOPROSTOL",
"productndc": "54348-148",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "ug/1",
"application_number": "ANDA091667",
"marketing_category": "ANDA"
}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.