United States· US:71335-1183_3c1e7d73-b9c0-4260-87ed-049797c1e8dc
Diclofenac Sodium and Misoprostol
A medicinal product containing diclofenac sodium; misoprostol, registered in United States by Bryant Ranch Prepack.
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
- Bryant Ranch Prepack
- 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 · 10
- ndc11713351183120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-1)
- ndc11713351183214 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-2)
- ndc11713351183360 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-3)
- ndc11713351183430 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-4)
- ndc11713351183510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-5)
- ndc1171335-1183-1
- ndc1171335-1183-2
- ndc1171335-1183-3
- ndc1171335-1183-4
- ndc1171335-1183-5
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 75PFIZER CANADA ULC
- PolandArthrotec ForteMedezin Sp. z o.o.
- United KingdomArthrotec 50 gastro-resistant tabletsWaymade Healthcare Plc
- NetherlandsArthrotec 50, tabletten met gereguleerde afgifteEuro Registratie Collectief B.V.
- IrelandArthrotec 50 modified-release tabletsPfizer Healthcare Ireland Unlimited Company
- 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/68b7bc43-3c57-4779-8167-d1e3d12f577e GET /v1/drugs/68b7bc43-3c57-4779-8167-d1e3d12f577e?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": "75; 200",
"substance": "DICLOFENAC SODIUM; MISOPROSTOL",
"productndc": "71335-1183",
"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.