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: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: 034bcbad-f57f-4338-a193-7a5aa9f09aa6
SPL ID: 5ddd44f1-1baa-4730-b718-5d1c326ecd49
Version: 3
Effective date: 2026-02-12
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:48:57

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	214473	derived:openfda.application_number
application number		ANDA214473	openfda.application_number
brand name		Esomeprazole Magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-840-05	openfda.package_ndc
ndc	package	58602-840-61	openfda.package_ndc
ndc	package	58602-840-62	openfda.package_ndc
ndc	product	58602-840	openfda.product_ndc
ndc11	package	58602084062	derived:openfda.package_ndc
ndc11	package	58602084005	derived:openfda.package_ndc
ndc11	package	58602084061	derived:openfda.package_ndc
rxcui		433733	openfda.rxcui
spl id		5ddd44f1-1baa-4730-b718-5d1c326ecd49	id
spl set id		034bcbad-f57f-4338-a193-7a5aa9f09aa6	set_id
unii		36H71644EQ	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.