Nitrofurantoin shortage — US supply status & alternatives

Nitrofurantoin

—

🇦🇺 AUST R 319275 · Emcure Pharmaceuticals Pty Ltd

Anticipated · Australia

ARX-Nitrofurantoin

Anticipated · 🇦🇺 Australia & also short in🇺🇸 US🇳🇴 NO

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$9.27DPMQ A$24.03details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Sept 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Nitrofurantoin
Brand names	ARX-Nitrofurantoin
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Emcure Pharmaceuticals Pty Ltd, Micro Labs Pty Ltd, Boucher & Muir Pty Ltd, Generics (UK) Limited +6 more
Registrations on file	19
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$9.27

AEMP

Dispensed (DPMQ)

A$24.03

incl. fees

Pack

nitrofurantoin 50 mg capsule, 30

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£3.73

Drug Tariff

🇺🇸 US

US$0.31

Acquisition

🇪🇸 ES

€4.89

Retail price

🇮🇹 IT

€7.08

Retail price

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

11 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.

Low concentration risk

Maithri Drugs Private LTDMacleods Pharmaceuticals LTDFis Fabbrica Italiana Sintetici SPATapi Nl BVUnimark Remedies LTDJinan Jinda Pharmaceutical Chemistry CO LTD+5 more

Manufacturing countries: India, Finland · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Nitrofurantoin Capsules

AvKARE · Dec 2024

Class IIdetails ↗

🇺🇸

Nitrofurantoin Capsules

American Health Packaging · May 2022

Class IIIdetails ↗

🇺🇸

NITROFURANTOIN

LUPIN SOMERSET · Dec 2018

Class IIdetails ↗

🇺🇸

Nitrofurantoin Capsules

Sandoz Inc · Nov 2018

Class IIIdetails ↗

🇺🇸

NITROFURANTOIN

LUPIN SOMERSET · June 2018

Class IIdetails ↗

🇺🇸

Nitrofurantoin Oral Suspension

Nostrum Laboratories, Inc. · May 2016

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders19 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
Em	50 mg	—	🇦🇺 AU	Emcure Pharmaceuticals Pty Ltd	Active
NITRODANTIN nitrofurantoin	50 mg	—	🇦🇺 AU	Micro Labs Pty Ltd	Active
Em	100 mg	—	🇦🇺 AU	Emcure Pharmaceuticals Pty Ltd	Active
ARX-Nitrofurantoin	50 mg	—	🇦🇺 AU	—	Active
Bnm	50 mg	—	🇦🇺 AU	Boucher & Muir Pty Ltd	Active
ARX-Nitrofurantoin	100 mg	—	🇦🇺 AU	—	Active
NITROFURANTOIN 50 MG HARD CAPSULES	50 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
NITROFURANTOIN 100 MG HARD CAPSULES	100 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
NITROFURANTOIN 50 MG TABLETS	50 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
NITROFURANTOIN 100 MG TABLETS	100 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
NITROFURANTOIN 50MG CAPSULES, HARD	50MG	capsule	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
NITROFURANTOIN 100MG CAPSULES, HARD	100MG	capsule	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
NITROFURANTOIN 25MG/5ML ORAL SUSPENSION	25MG	suspension	🇬🇧 GB	STRANDHAVEN LIMITED	Active
Nitrofurantoin Cnx Therapeutics	100 MG	capsule	🇬🇧 GB	CNX THERAPEUTICS LIMITED	Active
NITROFURANTOIN 50 MG CAPSULES	50 MG	capsule	🇬🇧 GB	MORNINGSIDE HEALTHCARE LIMITED	Active

+4 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.