United States· US:72245-683_4c0a051e-78a7-de5f-e063-6294a90a90c9
Prolate
A medicinal product containing acetaminophen; oxycodone hydrochloride, registered in United States by Forte Bio-Pharma 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
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Manufacturer
- Forte Bio-Pharma LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 12, 2026
Packs & prices · 4
- ndc11722456830330 TABLET in 1 BOTTLE, PLASTIC (72245-683-03)
- ndc117224568310100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10)
- ndc1172245-683-03
- ndc1172245-683-10
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.
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/c59c5586-b077-4081-8959-ff2308e571cf GET /v1/drugs/c59c5586-b077-4081-8959-ff2308e571cf?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": "300; 10",
"substance": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"productndc": "72245-683",
"dosage_form": "TABLET",
"dea_schedule": "CII",
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA040608",
"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.