FDA.reportPublic FDA data

NDC 80425-0331-03 - 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
80425-0331-03
Package NDCs from labels
80425-0331-1, 80425-0331-2, 80425-0331-3, 80425-0331-03
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 1 of 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole Magnesium for delayed-release oral suspensionESOMEPRAZOLE MAGNESIUMTorrent Pharmaceuticals Limitedf907e633-4080-44ae-829f-1414978769222026-09-02Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLEAmazon.com Services LLC90d6a679-2968-4b20-a2a6-f3a9908a7e2e2026-08-27WarningsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMGolden State Medical Supply, Inc.43cf2754-3ec7-75f7-e063-6394a90adfeb2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEAmazon.com Services LLC8f4e5461-8bbb-4e68-a765-4a52d8f0ba992026-08-19WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAmerican Health Packaging9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb2026-08-19Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606726
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC4ba317eb-e007-4c97-b382-2b7cac0f68452026-08-13WarningsExact identifier
rxcui: 606726
GoodMeds Acid Reducer 24HR Esomeprazole Magnesium Delayed-Release 20mgESOMEPRAZOLE MAGNESIUM 20MGCabinet Health P.B.C.58cbd617-cff5-ad52-e063-6394a90a72472026-08-11WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED19fa87e4-8225-4969-9857-1bf43db4427b2026-07-31WarningsExact identifier
rxcui: 606726
ESOMEPRAZOLE MAGNESIUM MINISESOMEPRAZOLE MAGNESIUM DIHYDRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc1435a38-b816-45a1-a0f6-4ad0c5b6da582026-07-27WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71a4fa85-032b-4f50-a2ee-fd9642ae8b152026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.65b892f2-8385-4bb0-8121-a58b01e8d13d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLERite Aid Corporation6996642f-a63e-4be9-aefd-0634e9914c2b2026-07-07WarningsExact identifier
rxcui: 606726
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LPcfd4ef00-cfc4-4794-99fe-faa45eb2f6172026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions6ad71713-39da-460b-81fc-e5fba103b2152026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack81f5f7d9-14bb-4804-975e-65d96f91785f2026-06-18Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Basic Care Esomeprazole MagnesiumESOMEPRAZOLEAmazon.com Services LLC42dd2e93-776c-4f49-b590-afc7dab6ef2f2026-06-17WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMREMEDYREPACK INC.e6e1906f-60be-402f-97f4-6d7bea1a6c082026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepackfed0e554-7d61-4957-9b91-356f3abc07772026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
EsomeprazoleESOMEPRAZOLE MAGNESIUMOhm Laboratories Inc.e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c42026-06-06WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
EsomeprazoleESOMEPRAZOLE MAGNESIUMGERI-CARE PHARMACEUTICALS, CORP53a21928-8f5b-52c1-e063-6294a90add6c2026-06-06WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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