FDA.reportPublic FDA data

NDC 65862-784-10 - 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
65862-784
Requested NDC
65862-784-10
Package NDCs from labels
65862-784-30, 65862-784-90, 65862-784-01, 65862-784-99, 65862-784-10, 65862-784-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2025-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esomeprazole Magnesium - Aurobindo Pharma LimitedAurobindo Pharma Limited2025-03-26Human Prescription Drug Label
Esomeprazole Magnesium - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2024-09-16HUMAN PRESCRIPTION DRUG LABEL
Esomeprazole Magnesium - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2020-05-14HUMAN PRESCRIPTION DRUG LABEL
Esomeprazole Magnesium - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2018-01-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-784-01Esomeprazole Magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE10015
65862-784-10Esomeprazole Magnesium10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1015
65862-784-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3015
65862-784-78Esomeprazole Magnesium10 in 1 CARTONCAPSULE, DELAYED RELEASE1015
65862-784-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE9015
65862-784-99Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-784ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 6 package rows20250417_f4ae091d-9b74-4a0e-ac68-057effd91e17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-784-30EA - Each65862-78487b9131b-9e7a-48ca-820b-83be58b67c9112016-12-07
65862-784-90EA - Each65862-78474b427bf-b382-462b-840f-177111a0114712016-12-07

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 191 of 324 · 6,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Apple Pear CloveETHYL ALCOHOL 70%MY IMPORTS USA LLC36a67d51-c80f-b8a9-e063-6394a90ac7be2025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a68ecb-3216-eeb2-e063-6294a90a5bba2025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%MY IMPORTS USA LLC36a7b358-131c-88fc-e063-6394a90a007f2025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a7bbf0-166b-54dc-e063-6294a90a1c162025-06-03WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizer Sprays (Blissful Cherry, Candy Cane Cocoa, Molten Marshmallows)ALCOHOLScent Theory Products LLC36b0eec0-33b2-2055-e063-6394a90af7302025-06-03WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizer Sprays (Pink Champagne, Harvest Berry, Cozy Coconut)ALCOHOLScent Theory Products LLC36b105ef-82a5-7f95-e063-6394a90a8c1b2025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%MY IMPORTS USA LLC36b4fb1c-9b19-63c3-e063-6394a90a5e352025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b55178-6f31-85a9-e063-6394a90a56bc2025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b5ebda-1448-bc40-e063-6294a90af6d42025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b63138-8ec9-e84a-e063-6394a90a68e32025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%MY IMPORTS USA LLC36b6d0e4-8d9f-9df5-e063-6294a90af3262025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%MY IMPORTS USA LLC36b71ebe-0638-73e8-e063-6394a90a9f4e2025-06-03WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%MY IMPORTS USA LLC36b73e99-293a-865b-e063-6394a90a39c42025-06-03WarningsExact identifier
unii: 3K9958V90M
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
Up and Up Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMTarget Corporationb3d3ad1d-96f8-4f72-ae66-f14940a628822025-06-02WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a5a4a2-983e-a4e7-e063-6394a90aa27c2025-06-01WarningsExact identifier
unii: 3K9958V90M
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Barbie HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3b78f9d0-2f6c-432f-98d2-c5d7c48c4c4a2025-05-30WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Cherry Burst ScentedALCOHOLFOURSTAR GROUP USA, INC.5334511c-55be-459d-8efa-eeb3780172172025-05-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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