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 8 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacydcaaf24a-0fb9-41b9-881a-00fa60796ca92024-08-06WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMMeijer Distribution Inc1dd30fec-15f4-44b2-a38f-e59ff4da206d2024-08-06WarningsExact identifier
rxcui: 606726
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
up and up esomeprazole magnesiumESOMEPRAZOLETarget Corporation717e5d5b-4bf7-415e-b259-44056bc96d8b2024-08-01WarningsExact identifier
rxcui: 606726
kirkland signature esomeprazole magnesiumESOMEPRAZOLECostco Wholesale Company4a87d5d5-c98b-4dc5-81be-50183342b0472024-08-01WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAdvanced Rx of Tennessee, LLC1e92676a-6c59-796d-e063-6294a90aaab42024-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606726
unii: R6DXU4WAY9
Good Neighbor Pharmacy Esomeprazole MagnesiumESOMEPRAZOLEAmerisource Bergenb596055c-98b2-47b1-b174-ae7ad3ba97ee2024-07-30WarningsExact identifier
rxcui: 606726
Exchange Select Esomeprazole MagnesiumESOMEPRAZOLEArmy & Air Force Exchange Service5fa9089f-90d1-48b6-bb79-c6171eeeaa032024-07-26WarningsExact identifier
rxcui: 606726
signature care esomeprazole magnesiumESOMEPRAZOLESafeway238b27e3-6993-4213-b7eb-062309398d1b2024-07-26WarningsExact identifier
rxcui: 606726
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companye54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2024-07-26WarningsExact identifier
rxcui: 606726
signature care esomeprazole magnesiumESOMEPRAZOLESafeway972bb479-7146-454d-ace4-f9314f0e584e2024-07-26WarningsExact identifier
rxcui: 606726
basic care esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC0b115351-318c-4bd9-935c-704a09bcdf522024-07-25WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLEKroger Companyda02c079-ed18-4896-896d-0489c8f435542024-07-25WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLEMeijer Distribution Inc126c269b-260d-40f4-879d-169c09251c672024-07-25WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAdvanced Rx of Tennessee, LLC1d8bd104-66d4-8c19-e063-6394a90a3cb62024-07-18Warnings, Adverse reactionsExact identifier
application number: ANDA211977
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCamber Pharmaceuticals, Inc.c18067ba-26ba-40b4-a328-3011710be2162024-07-12Warnings, Adverse reactionsExact identifier
application number: ANDA211977
ndc (product): 31722-665
rxcui: 606726
rxcui: 606730
spl id: 1d0ba185-85a8-988b-e063-6394a90a5fff
spl set id: c18067ba-26ba-40b4-a328-3011710be216
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack009794ae-8199-4176-9dc6-4c5e752d845c2024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Incfab0b1fa-cf56-d97c-f026-1754cf5b792c2024-07-08WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Incfca35363-7d27-b8b3-14c0-56f6036520532024-06-24WarningsExact identifier
rxcui: 606726
unii: R6DXU4WAY9

Reported adverse events (FAERS/openFDA)#

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