Glyburide shortage — US supply status & alternatives

Glyburide

—

In supply · Australia

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

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Glyburide
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No
Marketing-authorisation holders	TEVA PHARMACEUTICALS USA, INC., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., A-S Medication Solutions, RISING PHARMA HOLDINGS, INC.

Registrations on file	12

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.

Other markets

🇺🇸 US

US$0.06

Acquisition

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

7 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

Cambrex Profarmaco Milano SrlUsv Private LTDApitoria Pharma Private LTDCadila Pharmaceuticals LTDZentiva KsSri Krishna Pharmaceuticals LTD+1 more

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

Recalls official enforcement reports

🇺🇸

Glyburide And Metformin Hydrochloride Tablets Usp

Teva Pharmaceuticals USA · Mar 2014

Class IIdetails ↗

🇺🇸

Glyburide

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Glyburide

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders12 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
Glyburide	1.5mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Discontinued
Glyburide	3mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Discontinued
Glyburide	6mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Discontinued
Glyburide	1.25mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Glyburide	2.5mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Glyburide	5mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
glyburide-metformin hydrochloride	1.25; 250mg/1; mg/1	tablet	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
glyburide-metformin hydrochloride	2.5; 500mg/1; mg/1	tablet	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
glyburide-metformin hydrochloride	5; 500mg/1; mg/1	tablet	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
Glyburide and Metformin Hydrochloride	2.5; 500mg/1; mg/1	tablet	🇺🇸 US	A-S Medication Solutions	Active
Glyburide and Metformin Hydrochloride	5; 500mg/1; mg/1	tablet	🇺🇸 US	A-S Medication Solutions	Active
Glyburide and Metformin Hydrochloride	1.25; 250mg/1; mg/1	tablet	🇺🇸 US	RISING PHARMA HOLDINGS, INC.	Active

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.