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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209450

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NDA 209450 describes LUBIPROSTONE, which is a drug marketed by Amneal, Ascent Pharms Inc, Dr Reddys, Ph Health, Teva Pharms Usa Inc, and Zydus Pharms, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the LUBIPROSTONE profile page.

The generic ingredient in LUBIPROSTONE is lubiprostone. There are ten drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Summary for 209450

Tradename:	LUBIPROSTONE
Applicant:	Amneal
Ingredient:	lubiprostone
Patents:	0

Pharmacology for NDA: 209450

Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for 209450

Chloride Channel Agonists

Suppliers and Packaging for NDA: 209450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209450	ANDA	AvKARE	42291-475	42291-475-60	60 CAPSULE in 1 BOTTLE (42291-475-60)
LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209450	ANDA	AvKARE	42291-476	42291-476-60	60 CAPSULE in 1 BOTTLE (42291-476-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	8MCG
Approval Date:	Nov 30, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	24MCG
Approval Date:	Nov 30, 2021	TE:		RLD:	No

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