United States· US:12496-1208_ad5a289a-6285-4b2d-b7ad-e4812169dd58
Suboxone
A medicinal product containing buprenorphine hydrochloride; naloxone hydrochloride, registered in United States by INDIVIOR INC..
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
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Manufacturer
- INDIVIOR INC.
- 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
- ndc1112496-1208-3
- ndc11124961208330 POUCH in 1 CARTON (12496-1208-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1208-1)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/55917085-621f-4f42-9db5-0a40650a83a8 GET /v1/drugs/55917085-621f-4f42-9db5-0a40650a83a8?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": "BUCCAL; SUBLINGUAL",
"source": "ndc",
"strength": "8; 2",
"substance": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"productndc": "12496-1208",
"dosage_form": "FILM, SOLUBLE",
"dea_schedule": "CIII",
"strength_unit": "mg/1; mg/1",
"application_number": "NDA022410",
"marketing_category": "NDA"
}See everything about buprenorphine hydrochloride; naloxone 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.