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: LEADER/ CARDINAL HEALTH 110, INC.
Product type: HUMAN OTC DRUG
SPL set ID: aef20ccb-1eb7-4c79-af8e-81220eb73752
SPL ID: 08980e5c-b70f-43a1-97ec-1b3030a84628
Version: 2
Effective date: 2025-11-18
Source export date: 2026-11-06
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:44:53

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	209339	derived:openfda.application_number
application number		ANDA209339	openfda.application_number
brand name		Esomeprazole Magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		LEADER/ CARDINAL HEALTH 110, INC.	openfda.manufacturer_name
ndc	package	70000-0738-2	openfda.package_ndc
ndc	package	70000-0738-1	openfda.package_ndc
ndc	product	70000-0738	openfda.product_ndc
ndc11	package	70000073802	derived:openfda.package_ndc
ndc11	package	70000073801	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		08980e5c-b70f-43a1-97ec-1b3030a84628	id
spl set id		aef20ccb-1eb7-4c79-af8e-81220eb73752	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.