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 3 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWalgreen Company29eb7b87-59a4-4d27-ad53-789da7fec4272026-02-28WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions27e7f7f0-7403-4425-8baa-d12ae93213642026-02-11Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMYYBA CORP4a7f3a55-862f-111f-e063-6294a90a6a442026-02-10WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
members mark esomeprazole magnesiumESOMEPRAZOLESam's West Inc87913038-4b90-40a0-bce5-2d368bd5758c2026-02-07WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLEHyVee Incb0968243-171e-428a-b692-740e0c05a0fc2026-01-29WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMGLENMARK THERAPEUTICS INC., USAda5ec2c4-833e-4d2a-a61f-b43835c7f4732026-01-23WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Acid ReducerESOMEPRAZOLE MAGNESIUMCVS Pharmacy001817ea-906e-47f7-8605-41ba5a9abd212026-01-21WarningsExact identifier
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.b295a90e-320f-4414-b80a-d11f06c00c962026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions00aa81c2-73c7-4bf8-94e9-f644381b631f2026-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606726
unii: R6DXU4WAY9
equate esomeprazole magnesiumESOMEPRAZOLEWal-Mart Stores Incaaafc536-f846-4019-a629-b52b3f36e6822026-01-19WarningsExact identifier
rxcui: 606726
berkley and jensen heartburn treatmentESOMEPRAZOLEBJWC2369c948-d46f-4ace-bc51-47477631bc432026-01-19WarningsExact identifier
rxcui: 606726
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAjanta Pharma USA Inc.7ca657dc-4376-4693-8568-99351fac81862025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
NEXIUMESOMEPRAZOLE MAGNESIUMAstraZeneca Pharmaceuticals LPf4853677-1622-4037-688b-fdf533a11d962025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals, Inc.463c9b3b-dd6b-7ee7-e063-6394a90afb432025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMLannett Company, Inc.eb8f8b81-d482-4b94-be87-c766f49e753f2025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
EsomeprazoleESOMEPRAZOLE MAGNESIUMYYBA CORP0912d311-e26c-479d-9f13-ef0ac403e9b82025-11-19WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMLEADER/ CARDINAL HEALTH 110, INC.aef20ccb-1eb7-4c79-af8e-81220eb737522025-11-18WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLC212cca98-786f-4677-b687-fff81a1dd59f2025-11-14WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddys Laboratories Incb9605af1-a117-2fea-9f4b-bd4816d804e22025-11-04WarningsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc8bceb7b3-d0a4-6e53-6957-8104a6b927e42025-11-04WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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