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 259 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Dressed In WhiteALCOHOLBath & Body Works, Inc.1a8eaa81-c110-69f1-e063-6394a90ab2642024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ebd8c-f7c6-9bf8-e063-6394a90ad8a82024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ee169-fec2-d98a-e063-6294a90a19792024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus RainALCOHOLBath & Body Works, Inc.1a8f680b-ab3f-a550-e063-6394a90ac9512024-06-10WarningsExact identifier
unii: 3K9958V90M
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
unii: ND2M416302
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
unii: 3K9958V90M
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a361030-a925-0998-e063-6394a90a915d2024-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
unii: 15FIX9V2JP
b pure Hydrating Hand Sanitizer Salted Caramel ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38e171-e2fb-206c-e063-6294a90ac6382024-06-06WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Caramel Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38d19b-7c00-1c2b-e063-6394a90a4caa2024-06-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Calypso ClementineALCOHOLBath & Body Works, Inc.1a25084f-b8d7-1188-e063-6294a90a1e962024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Candy Apple CauldronALCOHOLBath & Body Works, Inc.1a251228-7fda-5a38-e063-6294a90a5d082024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.1a252344-cf76-752e-e063-6294a90a010f2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Chasing DaydreamsALCOHOLBath & Body Works, Inc.1a25aac4-34f8-0371-e063-6294a90ac0822024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Coffee and WhiskeyALCOHOLBath & Body Works, Inc.1a25de73-8740-c98d-e063-6394a90afffb2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.1a25f084-5228-b3ef-e063-6294a90a98822024-06-05WarningsExact identifier
unii: 3K9958V90M
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact identifier
unii: 15FIX9V2JP
Anti Bacterial Hand Gel Brightest BloomALCOHOLBath & Body Works, Inc.1a128ecb-230f-0882-e063-6294a90a41372024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Brown Sugar Toaster TreatALCOHOLBath & Body Works, Inc.1a12d9ca-fec4-2adc-e063-6394a90ab1812024-06-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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