United States· US:65162-436_0426969f-80c3-4157-b42a-ad57d204d011
Diclofenac Sodium and Misoprostol
A medicinal product containing diclofenac sodium; misoprostol, registered in United States by Amneal Pharmaceuticals LLC.
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
- DICLOFENAC SODIUM; MISOPROSTOL
- Manufacturer
- Amneal Pharmaceuticals LLC
- 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 · 8
- ndc1165162-436-03
- ndc1165162-436-06
- ndc1165162-436-09
- ndc1165162-436-10
- ndc11651624360330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-03)
- ndc11651624360660 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-06)
- ndc11651624360990 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-09)
- ndc116516243610100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-10)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Diclofenac sodium; misoprostol in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaARTHROTEC 50PFIZER CANADA ULC
- United KingdomArthrotec 50 gastro-resistant tabletsPfizer Ltd
- PolandArthrotecInPharm Sp. z o.o.
- NetherlandsArthrotec 50, tabletten met gereguleerde afgifteEuro Registratie Collectief B.V.
- IrelandArthrotec 50 modified-release tabletsPCO Manufacturing Ltd.
- FinlandArthrotecPfizer Oy
- SwitzerlandArthrotec 50, TablettenPfizer AG
- SwedenArthrotec 50 mg/0,2 mg Tablett med modifierad frisättningPfizer AB
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Arthrotec, Arthrotec Forte
- Belgium · Arthrotec
- Germany · Arthotec Forte
- Spain · Artrotec
- Finland · Arthrotec Forte
- United Kingdom (Northern Ireland) · Arthrotec
- Ireland · Arthrotec
- Italy · Artrotec
- Luxembourg · Arthrotec
- Netherlands · Arthrotec
- Norway · Arthrotec
- Poland · Arthrotec, Arthrotec Forte
- Portugal · Arthrotec, Diclofenac + Misoprostol Aurovitas
- Romania · Arthrotec
- Slovakia · Arthrotec Forte
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/fb04d0c8-5275-40a5-b0c4-eb31c1751846 GET /v1/drugs/fb04d0c8-5275-40a5-b0c4-eb31c1751846?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": "50; 200",
"substance": "DICLOFENAC SODIUM; MISOPROSTOL",
"productndc": "65162-436",
"dosage_form": "TABLET, DELAYED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; ug/1",
"application_number": "ANDA203995",
"marketing_category": "ANDA"
}See everything about diclofenac sodium; 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.