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 6 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMQuallent Pharmaceuticals Health LLC7362f930-0879-451e-8de9-8bb8565bfb7e2025-02-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBiocon Pharma Inc.,66c9e2bf-2dc4-4683-89fd-6dadf1b01ee92025-02-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPublixc45fd180-9d81-41e0-b7f8-025b8f29763a2025-02-21WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals,Inc.fe7d7aa8-4f46-83ae-e053-6394a90a01d62025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASEAllegiant Health42fa9084-89db-45ad-8212-4eeb53659a982025-01-30WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.2690dbe7-e559-4de8-9582-79b627af19642025-01-28Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack3f1c66f0-2d9d-4be1-8656-1dbed2c9c7152025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole DRESOMEPRAZOLE DRDirect_Rxe8937778-8baf-05f5-e053-2995a90a3a982025-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606726
unii: R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirect Rxd5f56bd4-3a59-6857-e053-2995a90a6e002025-01-21Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606730
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepackf3a3eea2-f6b3-4559-8536-26c1125df3e12025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba2025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack19aadd4b-647b-4c75-9059-9a2c68a185612025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLECVS Pharmacy6f1d75c1-3c0d-41c2-a625-1ee1bf642c322025-01-11WarningsExact identifier
rxcui: 606726
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC61f67858-ba2f-449b-8b30-c15cdaf492222025-01-09WarningsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMajor Pharmaceuticalsba65c73d-fc7d-491e-aaaa-cf45a77833952025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCfab87a2d-79c8-6045-e053-6394a90a23682024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA211977
ndc (package): 80425-0331-1
ndc (package): 80425-0331-2
ndc (package): 80425-0331-3
ndc (product): 80425-0331
ndc11 (package): 80425033101
rxcui: 606730
spl id: 2a9b9724-0260-e829-e063-6394a90a1c07
spl set id: fab87a2d-79c8-6045-e053-6394a90a2368
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.7b3af5a8-0c92-43f4-af13-7a47dca20e922024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited1ef3fe94-9bbb-934d-a09b-d19a1d23a4d52024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMGuardian Drug Company8d6c552c-16d9-4e0e-ba1a-04dce8052f952024-12-18WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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