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: Amerisource Bergen
Product type: HUMAN OTC DRUG
SPL set ID: 3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46
SPL ID: 3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46
Version: 1
Effective date: 2025-08-30
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:15

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	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		Amerisource Bergen	openfda.manufacturer_name
ndc	package	46122-821-59	openfda.package_ndc
ndc	package	46122-821-62	openfda.package_ndc
ndc	package	46122-821-61	openfda.package_ndc
ndc	product	46122-821	openfda.product_ndc
ndc11	package	46122082159	derived:openfda.package_ndc
ndc11	package	46122082162	derived:openfda.package_ndc
ndc11	package	46122082161	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46	id
spl set id		3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46	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.