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 5 of 10 · 186 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
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBiocon Pharma Inc.,66c9e2bf-2dc4-4683-89fd-6dadf1b01ee92025-02-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPublixc45fd180-9d81-41e0-b7f8-025b8f29763a2025-02-21WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals,Inc.fe7d7aa8-4f46-83ae-e053-6394a90a01d62025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASEAllegiant Health42fa9084-89db-45ad-8212-4eeb53659a982025-01-30WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.2690dbe7-e559-4de8-9582-79b627af19642025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole DRESOMEPRAZOLE DRDirect_Rxe8937778-8baf-05f5-e053-2995a90a3a982025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 606726
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirect Rxd5f56bd4-3a59-6857-e053-2995a90a6e002025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba2025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLECVS Pharmacy6f1d75c1-3c0d-41c2-a625-1ee1bf642c322025-01-11WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMajor Pharmaceuticalsba65c73d-fc7d-491e-aaaa-cf45a77833952025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCipla USA Inc.e89589f1-945e-429a-819e-61755cba77fa2025-01-02Warnings, Adverse reactionsExact identifier
unii: 36H71644EQ
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA205606
ndc (package): 80425-0111-2
ndc (package): 80425-0111-1
ndc (product): 80425-0111
ndc11 (package): 80425011101
rxcui: 606726
spl id: 2a99b1dd-becb-79f9-e063-6394a90a35f3
spl set id: b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c
unii: 36H71644EQ
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCfab87a2d-79c8-6045-e053-6394a90a23682024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMGuardian Drug Company8d6c552c-16d9-4e0e-ba1a-04dce8052f952024-12-18WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Inc0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02024-12-16WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack3a879cfc-b0a4-48ca-aa6a-b5e9051601aa2024-12-12Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDISCOUNT DRUG MART, INC.144fcd6b-2b40-f84b-c559-07a847b276382024-11-30WarningsExact identifier
rxcui: 606726
esomeprazoleESOMEPRAZOLEMacleods Pharmaceuticals Limitedd68c9247-91c7-4e0f-adc4-2cfa7446580f2024-11-30Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMZydus Lifesciences Limited6f314f5d-453c-4876-b9b8-20663008dfb12024-11-28Exact identifier
rxcui: 606726
rxcui: 606730
unii: 36H71644EQ

Reported adverse events (FAERS/openFDA)#

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