FDA.reportPublic FDA data

NDC 80425-0440-01 - Esomeprazole magnesium

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
80425-0440
Requested NDC
80425-0440-01
Package NDCs from labels
80425-0440-1, 80425-0440-2, 80425-0440-3, 80425-0440-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-10-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esomeprazole magnesium - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-10-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0440-1Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
80425-0440-2Esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
80425-0440-3Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0440ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241031_25a48082-ca99-42a4-e063-6394a90ae559.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0440-1EA - Each80425-0440e8f2489e-d41f-4ed0-9f5c-2ce0d982f99012024-12-10
80425-0440-2EA - Each80425-04403749e29b-2c71-4139-add9-e696d7c67ddf12024-12-10
80425-0440-3EA - Each80425-0440ac9afcff-ea35-4085-813e-63fb9ab38c2812024-12-10

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 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Esomeprazole MagnesiumESOMEPRAZOLEAmazon.com Services LLC90d6a679-2968-4b20-a2a6-f3a9908a7e2e2026-08-27WarningsExact identifier
rxcui: 606726
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMGolden State Medical Supply, Inc.43cf2754-3ec7-75f7-e063-6394a90adfeb2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
unii: R6DXU4WAY9
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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