United States· US:70069-671_d7e3d7be-ce38-4696-979c-64dd1023a4cd
Nalbuphine hydrochloride
A nalbuphine product containing nalbuphine hydrochloride, registered in United States by Somerset Therapeutics, LLC. The same ATC class is registered in 11 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Nalbuphine is registered in 11 of 19 countries.
Countries holding a registration under ATC N02AF02 (nalbuphine), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 7 of them publish a price we can compare per daily dose
Nalbuphine · ATC N02AF02
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Finlandprice
- Franceprice
- Germany
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- NALBUPHINE HYDROCHLORIDE
- Manufacturer
- Somerset Therapeutics, LLC
- Country
- United States (US)
- ATC code
- N02AF02
- ATC class
- Nalbuphine
- Defined daily dose
- 80 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1170069-671-10
- ndc11700696711010 AMPULE in 1 CARTON (70069-671-10) / 1 mL in 1 AMPULE (70069-671-01)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
148 interactions on record for nalbuphine.
Graded by severity as the source publishes them — 18 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Nalbuphine · interactions on record
148 records
- 18 severe
- 98 moderate
- 32 info
Most severe, free to view
- AlvimopanA06AH02severe
- OpiumA07DA02severe
- ChlorphenesinD01AE07severe
- ChlorphenesinG01AX21severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Nalbuphine in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomNalbuphine 20mg/2ml solution for injection ampoulesSpecial Order
- GermanyNalpainOrpha-Devel Handels Und Vertriebs Gmbh
- FranceNALBUPHINE RENAUDIN 20 mg/2 mL, solution injectableLABORATOIRE RENAUDIN
- PolandNalpain 10 mg/mlOrpha-Devel Handels und Vertriebs GmbH
- NetherlandsNalbufine HCl Orpha 10 mg/ml oplossing voor injectieOrpha Devel Handels-und Vertriebs GmbH
- FinlandNalpainOrpha-Devel Handels und Vertriebs GmbH
- CanadaNUBAIN INJECTION 10MG/MLSANDOZ CANADA INCORPORATED
- SwitzerlandNalbuphin OrPha, InjektionslösungOrPha Swiss GmbH
Authorised across Europe · EMA
The same active substance is authorised in 8 EEA countries. Names it is sold under:
- Austria · Nalbuphin Amomed, Nubain
- Czechia · Nalbuphin Orpha
- Germany · Nalpain, Nubain
- France · Nalbuphine Renaudin, Nalbuphine Serb
- Greece · Nalpain
- Hungary · Nalpain
- Netherlands · Nalbufine Hcl Orpha
- Poland · Nalpain
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/cb4d16c8-767f-4577-959a-80056baf026e GET /v1/drugs/cb4d16c8-767f-4577-959a-80056baf026e?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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"source": "ndc",
"strength": "10",
"substance": "NALBUPHINE HYDROCHLORIDE",
"productndc": "70069-671",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA216050",
"marketing_category": "ANDA"
}See everything about nalbuphine.
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.