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: c98b4332-ce47-422e-be54-f3eee0762354
SPL ID: 3fad3e71-9b6c-4b72-8637-2ac587b5861a
Version: 2
Effective date: 2025-04-24
Source export date: 2026-10-12
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/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:56:31

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	70000-0731-2	openfda.package_ndc
ndc	package	70000-0731-1	openfda.package_ndc
ndc	product	70000-0731	openfda.product_ndc
ndc11	package	70000073102	derived:openfda.package_ndc
ndc11	package	70000073101	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		3fad3e71-9b6c-4b72-8637-2ac587b5861a	id
spl set id		c98b4332-ce47-422e-be54-f3eee0762354	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.