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 78 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
unii: 3K9958V90M
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
unii: 3K9958V90M
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
unii: 3K9958V90M
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
unii: 3K9958V90M
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUnited Natural Foods, Inc. dba UNFIb63d9c12-8471-4db5-998b-ab46184495372026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUnited Natural Foods, Inc. dba UNFIccf505f6-2b34-4a18-af07-92ed505644ff2026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUline8ed759a2-fb0e-474e-8245-ddb798e542ff2026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUline3bc9cfa2-2b1f-4892-93ff-cffa9f5878042026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUlinefdda41fa-d847-4cee-a070-91f0600b0fc82026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel The Upside DownALCOHOLBath & Body Works, Inc.29a539bb-42e7-dc73-e063-6394a90a5fe92026-02-17WarningsExact identifier
unii: 3K9958V90M
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.38d661c8-6f48-f58c-e063-6294a90ae8c12026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.38951f0d-0ec4-2406-e063-6394a90a9fe32026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38d656e3-5f8f-9874-e063-6394a90a8ea52026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus MintALCOHOLBath & Body Works, Inc.38d65eae-f1af-f342-e063-6294a90af7fe2026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer OCEAN BREEZE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2cf4bc63-6157-4c4f-bb52-aa685f8d4aee2026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO15a5272c-0abc-47e1-be21-91a601ead3082026-02-17WarningsExact identifier
unii: 3K9958V90M
AURA LANE HAND SANITIZER Neroli Flower ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO1cd1c0ee-1849-4003-a128-323d1b06aa402026-02-17WarningsExact identifier
unii: 3K9958V90M
hand sanitizer chocolate chip pancake scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO105d2927-59e1-46fb-ad48-ea45ed3051e82026-02-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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