Is Nalbuphine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Nalbuphine, including Tonall (20 mg/ml, Solution for injection/infusion, SAR 31.05).

Is Nalbuphine approved by the US FDA?

Drugs@FDA lists 23 application product lines for Nalbuphine, including NALBUPHINE HYDROCHLORIDE (Prescription); NALBUPHINE HYDROCHLORIDE (Prescription); NALBUPHINE HYDROCHLORIDE (Prescription); NALBUPHINE HYDROCHLORIDE (Prescription); NALBUPHINE HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Nalbuphine?

US FDA: 1 entry (latest 2025-12-22).

Active substance

Nalbuphine

SFDA 1
US FDA 23
Health Canada 1
US price lines 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Tonall	20 mg/ml	Solution for injection/infusion · Intravenous, Intramuscular, Subcutaneous	5 Ampoule	SAR 31.05	Generic · Prescription	Amoun Pharmaceutical Company	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	HOSPIRA	Prescription	3 Feb 1989
NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	HOSPIRA	Prescription	3 Feb 1989
NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	HOSPIRA	Prescription	3 Feb 1989
NALBUPHINE HYDROCHLORIDE	200MG/10ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	HOSPIRA	Prescription	3 Feb 1989
NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML); 200MG/10ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	SOMERSET THERAPS LLC	Prescription	19 Sep 2024
NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML); 20MG/ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	SOMERSET THERAPS LLC	Prescription	19 Sep 2024
NUBAIN	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 20MG/ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 20MG/2ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 200MG/10ML (20MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · intramuscular, intravenous, subcutaneous	PH HEALTH	Discontinued	15 May 1979
NALBUPHINE	10MG/ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	ABRAXIS PHARM	Discontinued	2 Jul 1986
NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	ABRAXIS PHARM	Discontinued	2 Jul 1986
NALBUPHINE	20MG/ML (20MG/ML); 200MG/10ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	ABRAXIS PHARM	Discontinued	2 Jul 1986
NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	ABBOTT	Discontinued	3 Feb 1989
NALBUPHINE HYDROCHLORIDE	1.5MG/ML	injectable · injection	ABBVIE	Discontinued	12 Mar 1993
NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML); 200MG/10ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	DR REDDYS	Discontinued	19 Mar 1998
NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML); 20MG/ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	RISING	Discontinued	11 Jan 2019
NALBUPHINE HYDROCHLORIDE	100MG/10ML (10MG/ML); 200MG/10ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	RISING	Discontinued	6 Feb 2019
NALBUPHINE	10MG/ML	injectable · injection	QUAD PHARMS	Discontinued
NALBUPHINE	20MG/ML	injectable · injection	QUAD PHARMS	Discontinued
NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML); 100MG/10ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	IGI LABS INC	Discontinued
NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	IGI LABS INC	Discontinued
NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	solution · intramuscular, intravenous, subcutaneous	IGI LABS INC	Discontinued
NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML); 200MG/10ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	IGI LABS INC	Discontinued
NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	IGI LABS INC	Discontinued
NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	solution · intramuscular, intravenous, subcutaneous	IGI LABS INC	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NUBAIN INJECTION 10MG/ML	01913980	10 MG / ML	SOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NALBUPHINE 10 MG/ML AMPUL	$4.3216	per ML	18 Mar 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 NUBAIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for nalbuphine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.