FDA.reportPublic FDA data

NDC 80425-0331-01 - Esomeprazole Magnesium DR

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0331
Requested NDC
80425-0331-01
Package NDCs from labels
80425-0331-1, 80425-0331-2, 80425-0331-3, 80425-0331-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esomeprazole Magnesium DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0331-1Esomeprazole MagnesiumDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
80425-0331-2Esomeprazole MagnesiumDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
80425-0331-3Esomeprazole MagnesiumDR90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0331ESOMEPRAZOLE MAGNESIUM DR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_fab87a2d-79c8-6045-e053-6394a90a2368.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0331-1EA - Each80425-033109a6db3c-1ba1-41db-b733-8bb5688d40e812023-06-06
80425-0331-2EA - Each80425-0331b9ec7345-542f-4b24-8f5f-6fee820f341312023-06-06
80425-0331-3EA - Each80425-0331d7bd067b-5e67-4596-8a74-c7a10226c2c012023-06-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAmerisource Bergen3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db462025-08-30WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a652450-525b-4839-e063-6294a90ac2872025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc470496f5-a71d-40b2-bf11-3a8d3d7909622025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPHOENIX RX LLC3a6637ca-0c55-f648-e063-6294a90aaef72025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPD-Rx Pharmaceuticals, Inc.ac12cd05-10cf-4694-a9e8-e5f04fe162a72025-06-20Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULESAscend Laboratories, LLC277ce748-2809-4be0-81e7-6a4d604f2c6f2025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Up and Up Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMTarget Corporationb3d3ad1d-96f8-4f72-ae66-f14940a628822025-06-02WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLCb594f052-b6be-4d3b-9316-29cab050344a2025-05-20WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals,Inc.2879c79f-bf2a-0bc9-e063-6394a90a98ae2025-04-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMLEADER/ CARDINAL HEALTH 110, INC.c98b4332-ce47-422e-be54-f3eee07623542025-04-24WarningsExact identifier
rxcui: 606726
leader esomeprazole magnesiumESOMEPRAZOLECardinal Health 110, LLC. dba Leaderc9472b82-d345-4531-bf07-bd55c94876ab2025-04-23WarningsExact identifier
rxcui: 606726
Esomeprazole Magnesium Delayed ReleaseESOMEPRAZOLE MAGNESIUMWALGREENS2fa5d747-a014-2475-e063-6294a90ab9182025-04-21WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limited3c7a6b13-c67d-48f7-b170-1437a420d7042025-04-16Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limitede691b51e-2e31-4408-81c4-5afec6f9bbb62025-04-16Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.2d21ed0b-a089-46f4-9ebb-f24f9f3af61d2025-04-16Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limited7038a0bc-99b2-4a6e-9b9a-0646ec1877062025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCamber Consumer Care Incd2554c3d-eb0b-4bf8-aebc-18be7b195c8e2025-04-05WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limitedf4ae091d-9b74-4a0e-ac68-057effd91e172025-03-26Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLC5647bfb0-6af0-4580-b202-0f1fc9c412652025-03-13WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMScieGen Pharmaceuticals, Inc167340c2-1234-4d00-b4e2-cccf3d270fda2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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