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 2 of 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
24 HOUR Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMGrocery Outlet, Inc.4467134e-018f-2ad6-e063-6294a90a42bb2026-06-05WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole Magnesium Delayed-Release 20 mg (OTC)ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC)MARKSANS PHARMA LIMITED6a21f085-b60b-49b7-8098-99ccdc43dde32026-06-01WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMDoc Rx733a93ff-8240-4afa-ba28-b0a6f8514efe2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLCd0733d37-cc9c-41ba-9c5f-a0f8bf5a23642026-05-27WarningsExact identifier
rxcui: 606726
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companyf13088de-6841-453e-acb0-08bbdf9529d12026-05-20WarningsExact identifier
rxcui: 606726
Esomeprazole Magnesium for delayed-release oral suspensionESOMEPRAZOLE MAGNESIUMTorrent Pharmaceuticals Limited992b1830-55cc-4e95-8d6d-e7f796d5b3732026-05-06Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMH-E-B448bd1ea-baa2-7d6b-e063-6394a90ae5e02026-04-29WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.2164e1d7-e601-4ce5-be29-0c21c3a5a6472026-04-16Exact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNCS HealthCare of KY, LLC dba Vangard Labs28fbfa02-6c7b-4eb1-af24-86825e6523262026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.a9d05a38-08db-4710-b6f3-20c92ce885d52026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsb58bfbdb-939e-456e-827d-068e9d8088402026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions8a8ca4cf-076c-48c9-8613-f5a1bae87a492026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMProficient Rx LP5fd008ef-8388-48e9-8d38-76e0106bd5b62026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAvPAK4db9f4b8-b6df-f6e9-e063-6294a90a9f602026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
Acid ReducerESOMEPRAZOLE MAGNESIUMWalgreens4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc62026-03-25WarningsExact identifier
unii: R6DXU4WAY9
RIOPANESOMEPRAZOLEOPMX LLC4c37280d-25b6-ad2f-e063-6394a90a0b9d2026-03-24WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEHyVee Incc2308fc8-1549-476d-9769-2991051360ad2026-03-24WarningsExact identifier
rxcui: 606726
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
application number: ANDA211977
rxcui: 606730
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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