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 5 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
unii: 92RU3N3Y1O
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Esomeprazole MagnesiumESOMEPRAZOLECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED19fa87e4-8225-4969-9857-1bf43db4427b2026-07-31WarningsExact identifier
rxcui: 606726
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
unii: 92RU3N3Y1O
ESOMEPRAZOLE MAGNESIUM MINISESOMEPRAZOLE MAGNESIUM DIHYDRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc1435a38-b816-45a1-a0f6-4ad0c5b6da582026-07-27WarningsExact identifier
rxcui: 606726
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
unii: 92RU3N3Y1O
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71a4fa85-032b-4f50-a2ee-fd9642ae8b152026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 606730
unii: R6DXU4WAY9
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
unii: 92RU3N3Y1O
Naproxen and esomeprazole magnesiumNAPROXEN AND ESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.65b892f2-8385-4bb0-8121-a58b01e8d13d2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R6DXU4WAY9
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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