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: Camber Consumer Care Inc
Product type: HUMAN OTC DRUG
SPL set ID: d2554c3d-eb0b-4bf8-aebc-18be7b195c8e
SPL ID: 3203036c-7c7d-04ac-e063-6394a90a132b
Version: 5
Effective date: 2025-04-05
Source export date: 2026-10-30
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:27:23

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	212507	derived:openfda.application_number
application number		ANDA212507	openfda.application_number
brand name		Esomeprazole Magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		Camber Consumer Care Inc	openfda.manufacturer_name
ndc	package	69230-320-31	openfda.package_ndc
ndc	package	69230-320-32	openfda.package_ndc
ndc	package	69230-320-33	openfda.package_ndc
ndc	product	69230-320	openfda.product_ndc
ndc11	package	69230032031	derived:openfda.package_ndc
ndc11	package	69230032032	derived:openfda.package_ndc
ndc11	package	69230032033	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		3203036c-7c7d-04ac-e063-6394a90a132b	id
spl set id		d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	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.