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United States· US:50268-646_48ec761b-a7bc-59ef-e063-6294a90a579b

Oxycodone and Acetaminophen

A medicinal product containing acetaminophen; oxycodone hydrochloride, registered in United States by AvPAK.

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…normalisedOxycodone and AcetaminophenATC—REGISTER NO.US:50268-646_48ec761b…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Manufacturer
AvPAK
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 · 2

  • ndc11
    5026864615
    50 BLISTER PACK in 1 BOX (50268-646-15) / 1 TABLET in 1 BLISTER PACK (50268-646-11)
  • ndc11
    50268-646-15

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Acetaminophen; oxycodone hydrochloride in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All acetaminophen; oxycodone hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Greece · Oxycodone Paracetamol Rafarm
  • Italy · Depalgos

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/10b6a307-9053-46c7-ae78-33a1ee8ba8c6
GET /v1/drugs/10b6a307-9053-46c7-ae78-33a1ee8ba8c6?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": "325; 10",
  "substance": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
  "productndc": "50268-646",
  "dosage_form": "TABLET",
  "dea_schedule": "CII",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA040778",
  "marketing_category": "ANDA"
}

See everything about acetaminophen; oxycodone hydrochloride.

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.