Last Updated: September 28, 2026

Details for New Drug Application (NDA): 021153

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NDA 021153 describes NEXIUM, which is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs. It is available from one supplier. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 021153

Tradename:	NEXIUM
Applicant:	Astrazeneca
Ingredient:	esomeprazole magnesium
Patents:	0

Pharmacology for NDA: 021153

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 021153

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153	NDA	AstraZeneca Pharmaceuticals LP	0186-5020	0186-5020-31	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31)
NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153	NDA	AstraZeneca Pharmaceuticals LP	0186-5020	0186-5020-54	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 20MG BASE
Approval Date:	Feb 20, 2001	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 40MG BASE
Approval Date:	Feb 20, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021153

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001	4,636,499	⤷ Start Trial
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	5,599,794	⤷ Start Trial
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	4,255,431	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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