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 9 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMLITTLE PHARMA, INC.e45621ea-cc15-4a8e-98d2-d10ab424a45e2024-06-17WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.83fa2aab-f00d-4428-b961-d960247d71692024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack925cee78-83af-480f-838d-8ba97ac6b1e32024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack596e1cf8-dc6e-48b0-95ae-b463955870f72024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 606726
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCipla USA Inc.180490d1-c165-4bb9-96b1-12e727256e4e2024-05-16Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Nexium 24HRESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsd56b330a-4355-4636-9d26-c592f67cea562024-05-14WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
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
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMINNOVUS PHARMACEUTICALS, INC.a32039b7-8475-4ec5-abaf-07f9aee3954b2024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMFamily Dollar Stores, LLCf86ba9b5-736e-b279-e053-6394a90acf7c2024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAhold U.S.A., Inc,7bb719a0-9836-6752-e053-2a91aa0a2f482024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBetter Living Brands LLCee6e3f66-4eb9-4094-afcc-aaa020942b392024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBest Choice56120925-28e3-4e6c-b54d-490d7460984f2024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWALGREEN CO.f9e10472-c6a3-402c-b6a2-f8700ad73e9f2024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLCf9a5431a-ea03-441f-9064-6e7f30b616742024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWal-Mart Stores, Inc.c14f096d-ea1f-4539-8ad0-bb9907745cfc2024-04-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBETTER LIVING BRANDS LLC.f2c06861-0324-93ed-e053-2995a90a59022024-04-20WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAmerisource Bergenc94eb997-07d4-4d2e-b213-9a0d51db41c02024-03-29WarningsExact identifier
rxcui: 606726
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
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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