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: TIME CAP LABORATORIES, INC.
Product type: HUMAN OTC DRUG
SPL set ID: 08acf79f-f50d-8416-e063-6294a90a2704
SPL ID: 08ad180e-e87a-ba6f-e063-6394a90a2bc7
Version: 1
Effective date: 2023-11-23
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:44:00

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 · 12 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	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		TIME CAP LABORATORIES, INC.	openfda.manufacturer_name
ndc	package	49483-718-41	openfda.package_ndc
ndc	product	49483-718	openfda.product_ndc
ndc11	package	49483071841	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		08ad180e-e87a-ba6f-e063-6394a90a2bc7	id
spl set id		08acf79f-f50d-8416-e063-6294a90a2704	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: -skin reddening -blisters -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.