Is Bupivacaine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Bupivacaine, including BETOLINA 5MG/ML INJECTION (5 mg/ml, Solution for injection, SAR 58.70); BUCAINE 0.25% VIAL (0.25 %, Injection, SAR 16.50); BUCAINE 0.5% solution for injection (0.5 %, Solution, SAR 16.95); Bucaine Spinal (5 mg/ml, Solution for injection, SAR 29.70); Bupivacaine for spinal anesthesia Aguettant (5 mg/ml, Solution for injection, SAR 39.60).

Is Bupivacaine approved by the US FDA?

Drugs@FDA lists 40 application product lines for Bupivacaine, including MARCAINE HYDROCHLORIDE (Prescription); MARCAINE HYDROCHLORIDE PRESERVATIVE FREE (Prescription); SENSORCAINE (Prescription); BUPIVACAINE HYDROCHLORIDE (Prescription); MARCAINE (Prescription).

Is Bupivacaine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bupivacaine: Exparel liposomal.

Is Bupivacaine on the WHO Model List of Essential Medicines?

Yes — 1.2. Local anaesthetics (core list): Local anaesthetics.

Are there safety signals or safety updates for Bupivacaine?

US FDA: 8 entries (latest 2024-11-21).

Active substance

Bupivacaine

SFDA 12
US FDA 40
EMA 1
Health Canada 10
US price lines 4
NHS prices 5
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BETOLINA 5MG/ML INJECTION	5 mg/ml	Solution for injection · Topical	5 Vial	SAR 58.70	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
BUCAINE 0.25% VIAL	0.25 %	Injection · Intravenous use	1 Vial	SAR 16.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
BUCAINE 0.5% solution for injection	0.5 %	Solution · Intravenous use	1 Vial	SAR 16.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Bucaine Spinal	5 mg/ml	Solution for injection · Intrathecal use	5 Ampoule	SAR 29.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Bupivacaine for spinal anesthesia Aguettant	5 mg/ml	Solution for injection · Intrathecal use	5 Ampoule	SAR 39.60	NCE · Prescription	Laboratoire Aguettant	Valid
MARCAINE INJ 0.5%	0.5 %	Solution for injection · Intravenous use	5 Ampoule	SAR 77.80	NCE · Prescription	Aspen Pharma Trading Limited	Valid
Pankaine 20 mg per 4 ml	5 mg/ml	Solution for injection · Intrathecal use	10 Ampoule	SAR 66.00	Generic · Prescription	Panpharma	Valid
BUPIVACAINE 0.25% STERILE PACK AMP.	0.25 %	Solution for injection · Intravenous use	1 Ampoule	SAR 18.35	Generic · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed
BUPIVACAINE 0.5% STERILE PACK AMP.	0.5 %	Solution for injection · Intravenous use	1 Ampoule	SAR 18.90	Generic · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed
MARCAINE INJ 0.5%	0.5 %	Solution for injection · Intravenous use	5 Ampoule	SAR 77.80	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
MARCAINE INJ. 0.25%	0.25 %	Solution for injection · Intravenous use	5 Ampoule	SAR 74.30	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
MARCAINE INJ. 0.25%	0.25 %	Solution for injection · Intravenous use	5 Ampoule	SAR 74.30	NCE · Prescription	Aspen Pharma Trading Limited	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANESTHESIA; POSTOPERATIVE PAIN

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

Product	Strength	Form · route	Applicant	Status	First approved
MARCAINE HYDROCHLORIDE	0.25%; 0.5%	injectable · injection	HOSPIRA	Prescription	3 Oct 1972
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%; 0.75%; 0.25%	injectable · injection	HOSPIRA	Prescription	3 Oct 1972
SENSORCAINE	0.25%; 0.5%; 0.75%	injectable · injection	FRESENIUS KABI USA	Prescription	30 Dec 1981
BUPIVACAINE HYDROCHLORIDE	0.5%	injectable · injection	HOSPIRA	Prescription	13 Jul 1983
MARCAINE	0.75%	injectable · spinal	HOSPIRA	Prescription	4 May 1984
SENSORCAINE	0.25%	injectable · injection	FRESENIUS KABI USA	Prescription	21 May 1986
SENSORCAINE	0.5%	injectable · injection	FRESENIUS KABI USA	Prescription	21 May 1986
SENSORCAINE	0.75%	injectable · injection	FRESENIUS KABI USA	Prescription	21 May 1986
BUPIVACAINE HYDROCHLORIDE	0.25%	injectable · injection	HOSPIRA	Prescription	17 Feb 1987
BUPIVACAINE HYDROCHLORIDE	0.5%	injectable · injection	HOSPIRA	Prescription	17 Feb 1987
BUPIVACAINE HYDROCHLORIDE	0.25%	injectable · injection	HOSPIRA	Prescription	17 Feb 1987
BUPIVACAINE HYDROCHLORIDE	0.75%	injectable · injection	HOSPIRA	Prescription	3 Mar 1987
BUPIVACAINE HYDROCHLORIDE	0.5%	injectable · injection	HOSPIRA	Prescription	3 Mar 1987
BUPIVACAINE HYDROCHLORIDE	0.5%	injectable · injection	HOSPIRA	Prescription	3 Mar 1987
BUPIVACAINE HYDROCHLORIDE	0.75%	injectable · spinal	HOSPIRA	Prescription	11 Dec 1987
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%; 0.25%; 0.75%	injectable · injection	ONESOURCE SPECIALTY	Prescription	18 Oct 2011
BUPIVACAINE HYDROCHLORIDE	0.25%; 0.5%	injectable · injection	ONESOURCE SPECIALTY	Prescription	18 Oct 2011
EXPAREL	133MG/10ML (13.3MG/ML); 266MG/20ML (13.3MG/ML)	injectable, liposomal · injection	PACIRA PHARMS INC	Prescription	28 Oct 2011
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%; 0.5%; 0.75%	injectable · injection	EUGIA PHARMA	Prescription	5 Nov 2013
BUPIVACAINE HYDROCHLORIDE	0.25%; 0.5%	injectable · injection	EUGIA PHARMA	Prescription	13 May 2016
BUPIVACAINE HYDROCHLORIDE	0.75%	injectable · spinal	B BRAUN MEDICAL	Prescription	2 Apr 2019
BUPIVACAINE HYDROCHLORIDE	0.75%	injectable · spinal	HUONS	Prescription	30 Dec 2019
BUPIVACAINE HYDROCHLORIDE	0.25%; 0.5%; 0.75%	injectable · injection	HIKMA PHARMS	Prescription	11 Feb 2021
BUPIVACAINE HYDROCHLORIDE	0.25%; 0.5%	injectable · injection	HIKMA PHARMS	Prescription	11 Feb 2021
BUPIVACAINE HYDROCHLORIDE	0.25%; 0.5%	injectable · injection	SOMERSET	Prescription	20 Nov 2023

15 more — full table

EMA European Union — centrally authorised medicines

Exparel liposomal Pacira Ireland Limited · Authorised · authorised 16 Nov 2020 · ATC N01BB01

Therapeutic indication (EMA)

Exparel liposomal is indicated: in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP	02460645	7.5 MG / ML	SOLUTION · INTRASPINAL	STERIMAX INC
BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP	02512424	7.5 MG / ML	SOLUTION · INTRASPINAL	OMEGA LABORATORIES LIMITED
BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP	02536714	7.5 MG / ML	SOLUTION · INTRASPINAL	FORMATIVE PHARMA INC.
BUPIVACAINE HYDROCHLORIDE INJECTION, USP	02488930	7.5 MG / ML	SOLUTION · EPIDURAL; RETROBULBAR	BAXTER CORPORATION
BUPIVACAINE INJECTION BP	02443686	2.5 MG / ML	SOLUTION · EPIDURAL; BLOCK/INFILTRATION	STERIMAX INC
BUPIVACAINE INJECTION BP	02443694	5 MG / ML	SOLUTION · EPIDURAL; BLOCK/INFILTRATION	STERIMAX INC
MARCAINE	02241917	150 MG / 20 ML	SOLUTION · RETROBULBAR; EPIDURAL	PFIZER CANADA ULC
MARCAINE	02305909	250 MG / 50 ML	SOLUTION · BLOCK/INFILTRATION	PFIZER CANADA ULC
SENSORCAINE	01976141	2.5 MG / ML	SOLUTION · EPIDURAL; BLOCK/INFILTRATION	ASPEN PHARMACARE CANADA INC.
SENSORCAINE	01976168	5 MG / ML	SOLUTION · EPIDURAL; BLOCK/INFILTRATION	ASPEN PHARMACARE CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BUPIVACAINE 0.25% 125 MG/50 ML VL	$0.04792	per ML	20 May 2026
US NADAC	BUPIVACAINE 0.25% VIAL	$0.04792	per ML	20 May 2026
US NADAC	BUPIVACAINE 0.5% 250 MG/50 ML VL	$0.08596	per ML	22 Apr 2026
US NADAC	BUPIVACAINE 0.5% VIAL	$0.08596	per ML	22 Apr 2026
NHS Drug Tariff	Bupivacaine 25mg/10ml (0.25%) solution for injection ampoules	£11.70	5 ampoule	1 Oct 2026
NHS Drug Tariff	Bupivacaine 25mg/10ml (0.25%) solution for injection ampoules	£17.50	20 ampoule	1 Oct 2026
NHS Drug Tariff	Bupivacaine 50mg/10ml (0.5%) solution for injection ampoules	£13.20	5 ampoule	1 Oct 2026
NHS Drug Tariff	Bupivacaine 50mg/10ml (0.5%) solution for injection ampoules	£7.56	10 ampoule	1 Oct 2026
NHS Drug Tariff	Bupivacaine 50mg/10ml (0.5%) solution for injection ampoules	£18.30	20 ampoule	1 Oct 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.

WHO WHO Model List of Essential Medicines (2025)

1.2. Local anaesthetics · core
Local anaesthetics
Parenteral > Locoregional injections > Spinal anaesthesia: 0.5% in 4 mL ampoule (hydrochloride) + 8% glucose solution | Parenteral > General injections > unspecified: 0.25% (hydrochloride); 0.5% (hydrochloride)

Safety signals and safety-related labeling changes

US FDA 21 Nov 2024 ZYNRELEF KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 9 Nov 2023 EXPAREL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Sep 2022 MARCAINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Jul 2022 SENSORCAINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Mar 2021 BUPIVACAINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Aug 2020 MARCAINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Aug 2020 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for bupivacaine →

Combinations containing Bupivacaine

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.