Esomeprazole Magnesium

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
Generic name: ESOMEPRAZOLE MAGNESIUM
Manufacturer: Guardian Drug Company
Product type: HUMAN OTC DRUG
SPL set ID: 8d6c552c-16d9-4e0e-ba1a-04dce8052f95
SPL ID: 2bf79146-3c41-4704-9100-035b049ee79e
Version: 5
Effective date: 2024-12-18
Source export date: 2026-11-06
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:32:19

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	216149	derived:openfda.application_number
application number		ANDA216149	openfda.application_number
brand name		Esomeprazole Magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		Guardian Drug Company	openfda.manufacturer_name
ndc	package	53041-666-07	openfda.package_ndc
ndc	product	53041-666	openfda.product_ndc
ndc11	package	53041066607	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		2bf79146-3c41-4704-9100-035b049ee79e	id
spl set id		8d6c552c-16d9-4e0e-ba1a-04dce8052f95	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 may include: · skin reddening · blisters · rash If an allergic reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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