Bupivacaine Hydrochloride shortage — US supply status & alternatives

Bupivacaine Hydrochloride

ATC N01BB01

🇦🇺 AUST R 297613 · Boucher & Muir Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇳🇿 NZ

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

ATC level 5
Active ingredient (INN)	Bupivacaine Hydrochloride

ATC level 4	N01BB

Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Boucher & Muir Pty Ltd, Aspen Pharmacare Australia Pty Ltd, Baxter Healthcare Pty Ltd, MERCURY PHARMACEUTICALS LIMITED +5 more

Registrations on file	21

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

6 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Moderate concentration risk

Excella GMBH And CO KgCambrex Karlskoga ABSocieta Italiana Medicinali Scandicci Sims SrlDishman Carbogen Amcis LTDMoehs Iberica SlApex Healthcare LTD

Manufacturing countries: Germany, Sweden, Italy, India, Spain · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Aug 2023

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA-FE · 2d ago

High

🇳🇿

New Zealand

Pharmac · 12d ago

High

🇨🇦

Canada

HC · just now

Medium

Recalls official enforcement reports

🇺🇸

BUPIVACAINE HYDROCHLORIDE

Huons Co., Ltd. · Apr 2026

Class IIdetails ↗

🇺🇸

BUPIVACAINE HYDROCHLORIDE

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2022

Class IIdetails ↗

🇺🇸

BUPIVACAINE HYDROCHLORIDE

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2022

Class IIdetails ↗

🇺🇸

BUPIVACAINE HYDROCHLORIDE

PFIZER, INC · May 2021

Class Idetails ↗

🇺🇸

MARCAINE

Hospira Inc., A Pfizer Company · Sept 2016

Class IIdetails ↗

🇺🇸

MARCAINE

Hospira Inc., A Pfizer Company · Sept 2016

Class IIdetails ↗

Verified timeline regulator events

🇳🇿 15 May 2026

high reported

🇺🇸 5 May 2026

medium reported

🇺🇸 2 Apr 2026

high reported

🇨🇦 9 Jan 2019

medium reported

🇨🇦 30 Mar 2018

medium reported

🇨🇦 20 Mar 2018

medium reported

Sources official regulators

🇨🇦

verified just now

verify ↗

🇺🇸

FDA

verified just now

verify ↗

🇺🇸

FDA-FE

verified 2d ago

verify ↗

🇳🇿

Pharmac

verified 12d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders21 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
BUPIVACAINE SPINAL HEAVY BNM bupivacaine hydrochloride	20 mg	—	🇦🇺 AU	Boucher & Muir Pty Ltd	Active
Marcain 0.125% With Fentanyl	0.125%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
BUPIVACAINE-BAXTER bupivacaine hydrochloride monohydrate	50 mg	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
BUPIVACAINE-BAXTER bupivacaine hydrochloride monohydrate	100 mg	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
BUPIVACAINE HYDROCHLORIDE 0.5%W/V SOLUTION FOR INJECTION	0.5%	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
BUPIVACAINE HYDROCHLORIDE 0.25%W/V SOLUTION FOR INJECTION	0.25%	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
Bupivacaine Hydrochloride 0.25% W/V Solution For	0.25%	injection	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
Bupivacaine Hydrochloride 0.5% W/V Solution For	0.5%	injection	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
BUPIVACAINE HYDROCHLORIDE 2.5 MG/ML SOLUTION FOR INJECTION	2.5 MG	injection	🇬🇧 GB	EUGIA (UK) LIMITED	Active
BUPIVACAINE HYDROCHLORIDE 5 MG/ML SOLUTION FOR INJECTION	5 MG	injection	🇬🇧 GB	EUGIA (UK) LIMITED	Active
BUPIVACAINE HYDROCHLORIDE 0.125%W/V SOLUTION FOR INFUSION	0.125%	solution	🇬🇧 GB	UNICORN PHARMACEUTICALS LIMITED	Active
BUPIVACAINE HYDROCHLORIDE 0.1%W/V SOLUTION FOR INFUSION	0.1%	solution	🇬🇧 GB	UNICORN PHARMACEUTICALS LIMITED	Active
Bupivacaine Hydrochloride	2.5mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Bupivacaine Hydrochloride	5mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Bupivacaine Hydrochloride	7.5mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active

+6 more registrations on file

Mederti Drug Report

Generated 4 July 2026 · Australia market · 4 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.