Details for New Drug Application (NDA): 022281

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NDA 022281 describes ZEGERID OTC, which is a drug marketed by Riley Consumer and is included in two NDAs. It is available from one supplier. Additional details are available on the ZEGERID OTC profile page.

The generic ingredient in ZEGERID OTC is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for 022281

Tradename:	ZEGERID OTC
Applicant:	Riley Consumer
Ingredient:	omeprazole; sodium bicarbonate
Patents:	0

Pharmacology for NDA: 022281

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Osmotic Activity Proton Pump Inhibitors
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 022281

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281	NDA	Riley Consumer Care LLC	82632-100	82632-100-01	1 BOTTLE in 1 CARTON (82632-100-01) / 14 CAPSULE in 1 BOTTLE
ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281	NDA	Riley Consumer Care LLC	82632-100	82632-100-03	1 BOTTLE in 1 CARTON (82632-100-03) / 42 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	20MG;1.1GM
Approval Date:	Dec 1, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022281

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	6,489,346	⤷ Subscribe
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	7,399,772	⤷ Subscribe
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	6,699,885	⤷ Subscribe
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	6,645,988	⤷ Subscribe
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