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 6 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMZydus Lifesciences Limited4cd9e802-c519-4593-bc38-947ad7f9b5672024-11-28Exact identifier
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMSomerset Therapeutics, LLC02893318-e394-5a8e-e063-6394a90a885a2024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMZydus Pharmaceuticals USA Inc.c4b0571e-7b09-441b-90be-bc653806812b2024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: 36H71644EQ
EsomeprazoleESOMEPRAZOLE MAGNESIUMINNOVUS PHARMACEUTICALS, INC.b3d10f0b-52af-408c-9b3d-f8f25f7c42bd2024-10-30WarningsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMAdvanced Rx of Tennessee, LLC25a48082-ca99-42a4-e063-6394a90ae5592024-10-29Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions42b8d3f5-d919-48dd-92e4-ed49488dd6642024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULESAsclemed USA, Inc.85a963c1-9c13-4eb7-826b-08d5a991fe282024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULESProficient Rx LPad05cdde-a9e9-4442-80c4-1b02f5ebf6b42024-10-01Warnings, Adverse reactionsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepackf99f95a2-60e4-4781-80a9-e5b12897dff12024-09-03Warnings, Adverse reactionsExact identifier
rxcui: 606730
topcare esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMTopco Associates LLC86384845-0bea-490b-b04a-5770ef88b6392024-09-01WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Good Sense Esomeprazole MagnesiumESOMEPRAZOLEL. Perrigo Company4a89b4b5-5c42-44ee-98a9-e26a237aaef72024-08-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack7778bf7c-52f7-44b3-ac2c-e5a25f6967b72024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULESBryant Ranch Prepackdb8a346e-dba1-41bc-b122-a1de868ee91a2024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack192c63f0-25ac-410e-ae75-62e96cbf6f9d2024-08-15Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack61cc0020-aab8-42a3-b0a6-93062f382c872024-08-12Warnings, Adverse reactionsExact identifier
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack2f1b1a56-b6c4-4e30-a1f7-12701aa5a5352024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacydcaaf24a-0fb9-41b9-881a-00fa60796ca92024-08-06WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMMeijer Distribution Inc1dd30fec-15f4-44b2-a38f-e59ff4da206d2024-08-06WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
DG Health Esomeprazole MagnesiumESOMEPRAZOLEDolgencorp Inc2b0e555d-3ed5-4ec4-82a6-855351c503b32024-08-02WarningsExact identifier
rxcui: 606726
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp, LLC8f974698-ce9c-4ffb-b77e-9bad2c2ee2a12024-08-01WarningsExact identifier
rxcui: 606726

Reported adverse events (FAERS/openFDA)#

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