Hyoscyamine Sulfate — supply status, manufacturers & alternatives

Hyoscyamine Sulfate

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In supply · Australia

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

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

Marketing-authorisation holders
Active ingredient (INN)	Hyoscyamine Sulfate
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
Controlled substance	No

Registrations on file	11

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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$2.71

Acquisition

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

1 API manufacturer

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.

Very high concentration risk

Hubei Biocause Heilen Pharmaceutical CO LTD

Manufacturing countries: China · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Hyoscyamine Sulfate

VIRTUS PHARMACEUTICALS OPCO II L · Sept 2016

Class Idetails ↗

🇺🇸

Hyoscyamine Sulfate

VIRTUS PHARMACEUTICALS OPCO II L · Sept 2016

Class Idetails ↗

🇺🇸

Hyoscyamine Sulfate

VIRTUS PHARMACEUTICALS OPCO II L · Sept 2016

Class Idetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders11 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
Hyoscyamine Sulfate	.125mg/1	tablet	🇺🇸 US	NCS HealthCare of KY, LLC dba Vangard Labs	Active
Hyoscyamine Sulfate	.375mg/1	tablet	🇺🇸 US	Laser Pharmaceuticals, LLC	Active
Hyoscyamine Sulfate ODT	.125mg/1	tablet	🇺🇸 US	Acella Pharmaceuticals, LLC	Active
Hyoscyamine Sulfate SL	.125mg/1	tablet	🇺🇸 US	Acella Pharmaceuticals, LLC	Active
Hyoscyamine Sulfate TAB	.125mg/1	tablet	🇺🇸 US	Acella Pharmaceuticals, LLC	Active
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide	.0194; .1037; 16.2; .0065mg/5mL; mg/5mL; mg/5mL; mg/5mL	elixir	🇺🇸 US	INGENUS PHARMACEUTICALS, LLC	Active
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide	.0194; .1037; 16.2; .0065mg/1; mg/1; mg/1; mg/1	tablet	🇺🇸 US	INGENUS PHARMACEUTICALS, LLC	Active
HYOSCYAMINE SULFATE	.5mg/mL	injection	🇺🇸 US	BPI LABS LLC	Active
Hyoscyamine Sulfate	.125mg/5mL	elixir	🇺🇸 US	Chartwell RX, LLC	Active
Hyoscyamine sulfate	.125mg/mL	solution	🇺🇸 US	Chartwell RX, LLC	Active
Hyoscyamine sulfate Sublingual	.125mg/1	tablet	🇺🇸 US	Chartwell RX, LLC	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.