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 114 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zep Hand Sanitizer WipesETHANOLZep Inc.99867fc5-820e-6d6b-e053-2a95a90a07932025-12-26WarningsExact identifier
unii: 3K9958V90M
Dark 30-Pack Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.46e0c74f-30d6-6c24-e063-6394a90ad4872025-12-26WarningsExact identifier
unii: ND2M416302
StellaLife Hand SanitizerALCOHOLStellaLife, Inc.a65b338d-5019-0cfc-e053-2a95a90ae8b22025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SUNDAE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedddda3587-1967-474a-8d9b-c6dad5448b2c2025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY KISS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited39c8767d-46e8-4b26-be52-e5ed7d090d3e2025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY CLOUDS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6cac3768-0622-4151-abf5-97903ce1ea0e2025-12-26WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Lavender ChamomileALCOHOLTazza Brands East Inc.3c9afa9e-5109-bd0b-e063-6394a90ad8e52025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Peppermint LemonALCOHOLTazza Brands East Inc.3ddd9fa7-5e24-0781-e063-6394a90ae9512025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Sweet Orange Vanilla SpiceALCOHOLTazza Brands East Inc.3dddc20c-5dba-2e19-e063-6394a90aac7f2025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER UNSCENTEDALCOHOLTazza Brands East Inc.3de26f8e-83ea-c04f-e063-6294a90ac0242025-12-25WarningsExact identifier
unii: 3K9958V90M
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
Tazza 70% Alcohol-Based Hand Sanitizing FoamALCOHOLTazza Brands East, Inc.33452d7a-0436-99bb-e063-6294a90ad8c42025-12-24WarningsExact identifier
unii: 3K9958V90M
tazza-X EXTREME 63% alcohol formula HAND SANITIZINGALCOHOLTazza Brands East Inc.3a073e9c-d6e6-e2d9-e063-6394a90a61532025-12-24WarningsExact identifier
unii: 3K9958V90M
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
AMORA Hand Sanitizer Mist StrawberryETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf545a-0f53-4fc0-e063-6294a90a89012025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist PeachETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf6f89-4a8d-86ad-e063-6294a90a97c32025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist WatermelonETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf871e-cb82-cf46-e063-6394a90a92962025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist CherryETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf95f1-a76e-c810-e063-6394a90a6e952025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA BREEZE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited82d9ae31-d6bc-4c74-8add-c4a2a4902c2a2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MINT CHOCOLATE CHIP ICE Cream SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedfa471391-2023-4b3a-b8f5-114dd93f9fe32025-12-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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