Esomeprazole Magnesium Delayed-Release Capsules, 20 mg

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 Delayed-Release Capsules, 20 mg
Generic name: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG
Manufacturer: MARKSANS PHARMA LIMITED
Product type: HUMAN OTC DRUG
SPL set ID: 32f26c74-3052-4a69-9dc7-d18f9d761a8b
SPL ID: 2c8804c8-f28d-4381-ad8b-708009989b57
Version: 6
Effective date: 2024-03-18
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:28:06

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	217264	derived:openfda.application_number
application number		ANDA217264	openfda.application_number
brand name		Esomeprazole Magnesium Delayed-Release Capsules, 20 mg	openfda.brand_name
brand name		Esomeprazole Magnesium Delayed-Release 20 mg mini	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG	openfda.generic_name
generic name		ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI	openfda.generic_name
manufacturer name		MARKSANS PHARMA LIMITED	openfda.manufacturer_name
ndc	package	25000-112-76	openfda.package_ndc
ndc	package	25000-075-76	openfda.package_ndc
ndc	product	25000-112	openfda.product_ndc
ndc	product	25000-075	openfda.product_ndc
ndc11	package	25000007576	derived:openfda.package_ndc
ndc11	package	25000011276	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		2c8804c8-f28d-4381-ad8b-708009989b57	id
spl set id		32f26c74-3052-4a69-9dc7-d18f9d761a8b	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 include: o skin reddening o blisters o rash If an allergic reaction occurs, stop use and seek medical attention right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.