Regulatory PathRegulatory requirements compared

Active substances

Bupivacaine + Epinephrine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.25%;0.0091MG/ML; 0.5%;0.0091MG/MLinjectable · injectionHOSPIRAPrescription3 Oct 1972
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.5%;0.0091MG/ML; 0.75%;0.0091MG/ML; 0.25%;0.0091MG/MLinjectable · injectionHOSPIRAPrescription3 Oct 1972
SENSORCAINE0.5%;0.0091MG/ML; 0.75%;0.0091MG/MLinjectable · injectionFRESENIUS KABI USAPrescription30 Dec 1981
SENSORCAINE0.25%;0.0091MG/MLinjectable · injectionFRESENIUS KABI USAPrescription13 Oct 1987
SENSORCAINE0.25%;0.0091MG/MLinjectable · injectionFRESENIUS KABI USAPrescription13 Oct 1987
SENSORCAINE0.5%;0.0091MG/MLinjectable · injectionFRESENIUS KABI USAPrescription13 Oct 1987
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLinjectable · injectionHOSPIRAPrescription16 Jun 1988
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLinjectable · injectionHOSPIRAPrescription16 Jun 1988
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.005MG/MLinjectable · injectionHOSPIRAPrescription16 Jun 1988
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.005MG/MLinjectable · injectionHOSPIRAPrescription16 Jun 1988
VIVACAINE0.5%;0.0091MG/MLinjectable · injectionSEPTODONTPrescription27 Sep 2006
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLinjectable · injectionHOSPIRADiscontinued13 Jul 1983
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLinjectable · injectionHOSPIRADiscontinued16 Jun 1988
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.005MG/MLinjectable · injectionHOSPIRADiscontinued16 Jun 1988
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.75%;0.005MG/MLinjectable · injectionHOSPIRADiscontinued16 Jun 1988

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MARCAINE024742470.0091 MG / ML; 5 MG / MLSOLUTION · BLOCK/INFILTRATIONSEPTODONT INC
MARCAINE E022419150.182 MG / 20 ML; 50 MG / 20 MLSOLUTION · BLOCK/INFILTRATION; EPIDURALPFIZER CANADA ULC
MARCAINE E02241916100 MG / 20 ML; 0.182 MG / 20 MLSOLUTION · EPIDURAL; BLOCK/INFILTRATIONPFIZER CANADA ULC
SENSORCAINE WITH EPINEPHRINE019761845 MCG / ML; 2.5 MG / MLSOLUTION · EPIDURAL; BLOCK/INFILTRATIONASPEN PHARMACARE CANADA INC.
SENSORCAINE WITH EPINEPHRINE019762065 MCG / ML; 5 MG / MLSOLUTION · BLOCK/INFILTRATION; EPIDURALASPEN PHARMACARE CANADA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffBupivacaine 25mg/10ml (0.25%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoules£46.0010 ampoule1 Oct 2026
NHS Drug TariffBupivacaine 50mg/10ml (0.5%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoules£51.7510 ampoule1 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.

Components

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.