Phenobarbital shortage — US supply status & alternatives

Phenobarbital

—

🇦🇺 AUST R 19758

Limited supply · Australia

PHENOBARB phenobarbital

In declared shortage · 🇦🇺 Australia & also short in🇺🇸 US🇧🇪 BE

Limited supply

Reading today’s signals…

🇦🇺 AUAEMPA$5.20DPMQ A$19.80details →

✓ Can I substitute?

Yes — approved substitute available

TGA s19A · phenobarbital-tablets-usp-30mg-rising-pharmaceuticals-usa

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

July 2026

Sponsor est. via TGA — may differ by brand

Active ingredient (INN)	Phenobarbital
Brand names	PHENOBARB phenobarbital
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	ACCORD-UK LIMITED, THORNTON & ROSS LIMITED, TEVA UK LIMITED, MACARTHYS LABORATORIES LIMITED +10 more
Registrations on file	30
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$5.20

AEMP

Dispensed (DPMQ)

A$19.80

incl. fees

Pack

phenobarbital 30 mg tablet, 200

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£0.92

Drug Tariff

🇺🇸 US

US$0.13

Acquisition

🇪🇸 ES

€1.06

Retail price

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · phenobarbital-tablets-usp-30mg-rising-pharmaceuticals-usa

TGA Section 19A: overseas-registered 'Phenobarbital Tablets, USP 30mg (Rising Pharmaceuticals, USA)' approved for import and supply in Australia during a shortage. Origin: Rising Pharmaceuticals, USA. Expires Aug 2026. Verify on TGA Section 19A approvals ↗

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

5 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

Siegfried USA LLCAlkaloida Chemical CO ZrtHarman Finochem LTDShandong Xinhua Pharmaceutical CO LTDNantong Jinghua Pharmaceutical CO LTD

Manufacturing countries: United States, India, China · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Phenobarbital Elixir

Monarch PCM, LLC · Apr 2022

Class IIIdetails ↗

🇺🇸

PHENOBARBITAL SODIUM

Vitae Enim Vitae Scientific, Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

PHENOBARBITAL SODIUM

Vitae Enim Vitae Scientific, Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

Phenobarbital Tablets

Cardinal Health Inc. · Mar 2021

Class IIdetails ↗

🇺🇸

Phenobarbital Oral Solution

Torrent Pharma Inc · May 2019

Class IIdetails ↗

🇺🇸

Phenobarbital Oral Solution

Lohxa LLC · Mar 2019

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 14 MA holders

Product	Strength	Form	Market	MA holder	Status
PHENOBARB phenobarbital	30mg	—	🇦🇺 AU	—	Active
Phenobarbital Accord Tablets Bp	30MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Phenobarbital Accord Tablets Bp	60MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Phenobarbital Thornton & Ross	15MG	phenobarbital	🇬🇧 GB	THORNTON & ROSS LIMITED	Active
Phenobarbital Teva	15 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Phenobarbital Teva	30 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Phenobarbital Teva	60 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Phenobarbital Sodium	30MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Phenobarbital Sodium	60MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Phenobarbital Sodium	200MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Phenobarbital Pharmvit	30 MG	tablet	🇬🇧 GB	PHARMVIT LIMITED	Active
Phenobarbital Pharmvit	60 MG	tablet	🇬🇧 GB	PHARMVIT LIMITED	Active
Phenobarbital Bristol Labs	15MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Phenobarbital Bristol Labs	30MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Phenobarbital Bristol Labs	60MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active

+15 more registrations on file

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.