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United States· US:85766-192_4dc17730-088f-451b-e063-6294a90a032c

Diclofenac Sodium/Misoprostol

A medicinal product containing diclofenac sodium; misoprostol, registered in United States by Sportpharm LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDiclofenac Sodium/MisoprostolATC—REGISTER NO.US:85766-192_4dc17730…PACKS LISTED16CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DICLOFENAC SODIUM; MISOPROSTOL
Manufacturer
Sportpharm 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 · 16

  • ndc11
    8576619207
    7 TABLET in 1 BOTTLE (85766-192-07)
  • ndc11
    8576619210
    10 TABLET in 1 BOTTLE (85766-192-10)
  • ndc11
    8576619214
    14 TABLET in 1 BOTTLE (85766-192-14)
  • ndc11
    8576619215
    15 TABLET in 1 BOTTLE (85766-192-15)
  • ndc11
    8576619220
    20 TABLET in 1 BOTTLE (85766-192-20)
  • ndc11
    8576619230
    30 TABLET in 1 BOTTLE (85766-192-30)
  • ndc11
    8576619260
    60 TABLET in 1 BOTTLE (85766-192-60)
  • ndc11
    8576619290
    90 TABLET in 1 BOTTLE (85766-192-90)
  • ndc11
    85766-192-07
  • ndc11
    85766-192-10
  • ndc11
    85766-192-14
  • ndc11
    85766-192-15
  • ndc11
    85766-192-20
  • ndc11
    85766-192-30
  • ndc11
    85766-192-60
  • ndc11
    85766-192-90

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.

All diclofenac sodium; misoprostol products

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/70b72413-c0bc-4908-963e-2930d4218e69
GET /v1/drugs/70b72413-c0bc-4908-963e-2930d4218e69?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": "85766-192",
  "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.