United States· US:71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456b
Diclofenac Sodium/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
- ndc1171335-2603-2
- ndc1171335-2603-3
- ndc1171335-2603-4
- ndc1171335-2603-5
- ndc11713352603120 TABLET in 1 BOTTLE (71335-2603-1)
- ndc11713352603214 TABLET in 1 BOTTLE (71335-2603-2)
- ndc11713352603360 TABLET in 1 BOTTLE (71335-2603-3)
- ndc11713352603430 TABLET in 1 BOTTLE (71335-2603-4)
- ndc11713352603510 TABLET in 1 BOTTLE (71335-2603-5)
- ndc1171335-2603-1
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.
- PolandArthrotec FortePfizer Europe MA EEIG
- United KingdomArthrotec 50 gastro-resistant tabletsWaymade Healthcare Plc
- CanadaARTHROTEC 50PFIZER CANADA ULC
- NetherlandsArthrotec 50, tabletten met gereguleerde afgiftePfizer 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/12fc3172-042b-4c0c-b099-6440b0a57780 GET /v1/drugs/12fc3172-042b-4c0c-b099-6440b0a57780?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": "71335-2603",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; ug/1",
"application_number": "ANDA204355",
"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.