Esomeprazole Magnesium Delayed Release

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Esomeprazole Magnesium Delayed Release
Generic name: ESOMEPRAZOLE MAGNESIUM
Manufacturer: WALGREENS
Product type: HUMAN OTC DRUG
SPL set ID: 2fa5d747-a014-2475-e063-6294a90ab918
SPL ID: 3347c9eb-2f69-d5b6-e063-6394a90aea81
Version: 2
Effective date: 2025-04-21
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:33:51

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	217264	derived:openfda.application_number
application number		ANDA217264	openfda.application_number
brand name		Esomeprazole Magnesium Delayed Release	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		WALGREENS	openfda.manufacturer_name
ndc	package	0363-7810-82	openfda.package_ndc
ndc	package	0363-7810-45	openfda.package_ndc
ndc	package	0363-7810-41	openfda.package_ndc
ndc	product	0363-7810	openfda.product_ndc
ndc11	package	00363781045	derived:openfda.package_ndc
ndc11	package	00363781041	derived:openfda.package_ndc
ndc11	package	00363781082	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		3347c9eb-2f69-d5b6-e063-6394a90aea81	id
spl set id		2fa5d747-a014-2475-e063-6294a90ab918	set_id
unii		R6DXU4WAY9	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert: Do not use if you are allergic to esomeprazole Esomeprazole may cause severe skin reactions. Symptoms include: - skin reddening - blisters -rash If an allergic reaction occurs, stop use and seek medical attention right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.