Codeine Phosphate shortage — NZ supply status & alternatives

Codeine Phosphate

ATC R05DA04

🇦🇺 AUST R 338093 · Sanofi-Aventis Australia Pty Ltd

In supply · Australia

Noumed

In supply · 🇦🇺 Australia · short in🇨🇦 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

Active ingredient (INN)	Codeine Phosphate
Brand names	Noumed
ATC level 5	R05DA04

ATC level 4	R05DA

Therapeutic category	Auto-created by Pharmac — New Zealand Medicine Supply Disruptions scraper

Controlled substance	No

Marketing-authorisation holders	Sanofi-Aventis Australia Pty Ltd, iNova Pharmaceuticals Australia Pty Ltd, Cipla Australia Pty Ltd, ACCORD-UK LIMITED +5 more

Registrations on file	17

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.

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

Chattem Chemicals INCSpecgx LLCSiegfried USA LLCVeranova LPNoramco LLC

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders17 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
APX-PARACETAMOL/CODEINE paracetamol	500 mg	—	🇦🇺 AU	Sanofi-Aventis Australia Pty Ltd	Active
Gold Cross Codeine Linctus codeine phosphate hemihydrate	5 mg	—	🇦🇺 AU	iNova Pharmaceuticals Australia Pty Ltd	Active
Cipla Pain Relief Paracetamol 500 + Codeine	500 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Codeine Phosphate Tablets Bp	15MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Codeine Phosphate Tablets Bp	30MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Codeine Phosphate Tablets Bp	60MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Thornton & Ross Codeine Phosphate	25MG	solution	🇬🇧 GB	THORNTON & ROSS LIMITED	Active
Bells Healthcare Codeine Linctus Bp Codeine Phosphate	15 MG	solution	🇬🇧 GB	BELL SONS & COMPANY (DRUGGISTS) LIMITED	Active
CODEINE PHOSPHATE 30MG TABLETS	30MG	tablet	🇬🇧 GB	WAYMADE PLC	Active
CODEINE PHOSPHATE 60MG TABLETS	60MG	tablet	🇬🇧 GB	WAYMADE PLC	Active
CODEINE PHOSPHATE 15MG TABLETS	15MG	tablet	🇬🇧 GB	WAYMADE PLC	Active
CODEINE PHOSPHATE 15MG TABLETS BP	15MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
CODEINE PHOSPHATE 30MG TABLETS BP	30MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
CODEINE PHOSPHATE 60MG TABLETS BP	60MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
CODEINE PHOSPHATE TABLETS 15 MG	15 MG	tablet	🇬🇧 GB	ACTIVASE PHARMACEUTICALS LIMITED	Active

+2 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.