FDA.reportPublic FDA data

NDC 80425-0111-01 - 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
80425-0111
Requested NDC
80425-0111-01
Package NDCs from labels
80425-0111-1, 80425-0111-2, 80425-0111-01
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
80425-0111-1Esomeprazole MagnesiumDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
80425-0111-2Esomeprazole MagnesiumDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0111ESOMEPRAZOLE MAGNESIUM DR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0111-1EA - Each80425-01113e6f84d4-e7ba-4e3a-bd57-e7977538a56712023-04-07
80425-0111-2EA - Each80425-0111757b17d7-2777-405b-bd39-e6ddf04789e812023-04-07

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 8 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.83fa2aab-f00d-4428-b961-d960247d71692024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack925cee78-83af-480f-838d-8ba97ac6b1e32024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: 36H71644EQ
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack596e1cf8-dc6e-48b0-95ae-b463955870f72024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: 36H71644EQ
Nexium 24HRESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsd56b330a-4355-4636-9d26-c592f67cea562024-05-14WarningsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCipla USA Inc.c1319da6-bf0d-4dd6-a713-1677bfbfbdae2024-05-13Warnings, Adverse reactionsExact identifier
unii: 36H71644EQ
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp Incd5a842f3-d21b-4ddf-87f1-e44daf5cfe052024-05-08WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacy, Inc.d226cda0-5cdb-4e2d-a865-530a8f09a0952024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMINNOVUS PHARMACEUTICALS, INC.a32039b7-8475-4ec5-abaf-07f9aee3954b2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMFamily Dollar Stores, LLCf86ba9b5-736e-b279-e053-6394a90acf7c2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAhold U.S.A., Inc,7bb719a0-9836-6752-e053-2a91aa0a2f482024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBetter Living Brands LLCee6e3f66-4eb9-4094-afcc-aaa020942b392024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBest Choice56120925-28e3-4e6c-b54d-490d7460984f2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWALGREEN CO.f9e10472-c6a3-402c-b6a2-f8700ad73e9f2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLCf9a5431a-ea03-441f-9064-6e7f30b616742024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWal-Mart Stores, Inc.c14f096d-ea1f-4539-8ad0-bb9907745cfc2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBETTER LIVING BRANDS LLC.f2c06861-0324-93ed-e053-2995a90a59022024-04-20WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAmerisource Bergenc94eb997-07d4-4d2e-b213-9a0d51db41c02024-03-29WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
esomeprazole magnesiumESOMEPRAZOLEMeijer, Inc.8799c88f-dafb-4be6-b279-a54d916162fe2024-03-25WarningsExact identifier
rxcui: 606726
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC4513934d-0cf0-40fc-a348-b4e75a33b0942024-03-19WarningsExact identifier
rxcui: 606726
Esomeprazole Magnesium Delayed-Release Capsules, 20 mgESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MGMARKSANS PHARMA LIMITED32f26c74-3052-4a69-9dc7-d18f9d761a8b2024-03-18WarningsExact identifier
rxcui: 606726

Reported adverse events (FAERS/openFDA)#

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