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 2 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companyf13088de-6841-453e-acb0-08bbdf9529d12026-05-20WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMH-E-B448bd1ea-baa2-7d6b-e063-6394a90ae5e02026-04-29WarningsExact identifier
rxcui: 606726
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.2164e1d7-e601-4ce5-be29-0c21c3a5a6472026-04-16Exact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNCS HealthCare of KY, LLC dba Vangard Labs28fbfa02-6c7b-4eb1-af24-86825e6523262026-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA205606
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.a9d05a38-08db-4710-b6f3-20c92ce885d52026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsb58bfbdb-939e-456e-827d-068e9d8088402026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions8a8ca4cf-076c-48c9-8613-f5a1bae87a492026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAvPAK4db9f4b8-b6df-f6e9-e063-6294a90a9f602026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEHyVee Incc2308fc8-1549-476d-9769-2991051360ad2026-03-24WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
EQUATE ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLEWALMART INC.ce5f2915-327d-4a91-b7fd-e399664a250f2026-03-19WarningsExact identifier
rxcui: 606726
Foster and Thrive Acid ReducerESOMEPRAZOLEStrategic Sourcing Services LLC32933772-c0ef-46ad-84e5-d70218bcc8662026-03-07WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMREMEDYREPACK INC.ab3d31c8-cab1-4c44-bacd-5e5c67dd13842026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWalgreen Company29eb7b87-59a4-4d27-ad53-789da7fec4272026-02-28WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLC034bcbad-f57f-4338-a193-7a5aa9f09aa62026-02-12WarningsExact identifier
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions27e7f7f0-7403-4425-8baa-d12ae93213642026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMYYBA CORP4a7f3a55-862f-111f-e063-6294a90a6a442026-02-10WarningsExact identifier
rxcui: 606726
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
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions00aa81c2-73c7-4bf8-94e9-f644381b631f2026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 606726

Reported adverse events (FAERS/openFDA)#

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