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 4 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWalgreensf0374954-e84f-ac82-1ace-3bad8628629a2025-11-04WarningsExact identifier
unii: R6DXU4WAY9
careone esomeprazole magnesiumESOMEPRAZOLEAmerican Sales Company3f9a2747-8afd-4898-bbfb-5f379293137e2025-11-03WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWalgreens Companyf97f8604-9f00-6ed5-ae25-fedc8cf36a5d2025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMKROGER COMPANYd001e9c2-1c70-7ff6-ad72-c431a46d17712025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCHAIN DRUG MARKETING ASSOCIATION INCf95053ab-d6c5-ee92-58d1-6f203873f79c2025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMHEBe3747f1e-01e7-f3cf-499e-c7c3f6d06a302025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.945beb4b-8a31-d904-8881-1cf8396043472025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMThe Kroger Co.b4cdf878-61d3-01bd-48c9-4d6f4fbc71df2025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWALGREENS COMPANY993f86d0-c18b-a843-6adf-e8a967da37452025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCHAIN DRUG MARKETING ASSOCIATION, INC.1edcb0be-7af2-c08c-dab2-0be03364a1402025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMH E Ba5a6f614-2920-d74c-1ddc-9a07a0ec6e052025-10-28WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.6368a3be-4b79-466b-8ec4-11fc3ac623cc2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPD-Rx Pharmaceuticals, Inc.fdea1f5f-b717-4d49-8d70-0b373c959bf02025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMGranules Pharmaceuticals Inc.651cfdb1-d7c7-45e6-add0-f40eea7722f72025-09-30Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLEPublix Super Markets Inc60554fd6-96d5-4e73-b676-332116caa8002025-09-29WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWalmart Inc.3863bc2c-3120-ad92-e063-6394a90abb202025-09-19WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMSun Pharmaceutical Industries, Incdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf2025-09-18Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
equate esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWALMART INC.2d40c4bf-5b66-420c-9f17-3f31edc40d1a2025-09-11WarningsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.1348fb0e-dcdc-475d-b394-f405dff00f362025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacy0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb2025-08-30WarningsExact identifier
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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