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 233 of 323 · 6,449 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELLOW HAND SANITIZER ALOEETHYL ALCOHOLL.e.d. Cosmetics, Inc.4377ba5e-21f6-407e-9b8c-25e3c6321a5b2024-12-10WarningsExact identifier
unii: 3K9958V90M
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
unii: 15FIX9V2JP
CVS Hand SanitizerALCOHOLCVSb5faeb31-67c7-2000-e053-2995a90a14092024-12-10WarningsExact identifier
unii: 3K9958V90M
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.4065c34c-d1ca-49bd-9fba-dfa21011592f2024-12-10WarningsExact identifier
unii: 3K9958V90M
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.ec37da5a-8ef7-474b-a5ec-b5edcee03f9d2024-12-10WarningsExact identifier
unii: 3K9958V90M
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEGERI-CARE PHARMACEUTICALS, CORP1f1dbf41-cb87-37d4-e063-6394a90ae2942024-12-09WarningsExact identifier
unii: 0E53J927NA
CSI E3 Hand SanitizerALCOHOLCentral Solutions Incaa07bb62-ef07-99e4-e053-2995a90ae4a82024-12-09WarningsExact identifier
unii: 3K9958V90M
DermaCen Instant Hand SanitizerALCOHOLCentral Solutions Inc36783d30-a222-40fe-a5ea-61a2842a34c92024-12-09WarningsExact identifier
unii: 3K9958V90M
DermaCen Instant Hand Sanitizer with AloeALCOHOLCentral Solutions Incdc6191ae-841f-48b6-b454-72d8d43fdcce2024-12-09WarningsExact identifier
unii: 3K9958V90M
DERMACEN FOAMING INSTANT HAND SANITIZER WITH ALOEALCOHOLCentral Solutions Incd56b9930-b8b0-ad72-e053-2a95a90af5902024-12-09WarningsExact identifier
unii: 3K9958V90M
Prevention Daily Tinted Moisturizer SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labsed883d63-777c-e924-e053-2995a90a162a2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
unii: 15FIX9V2JP
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
NEXXGEN 70% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC8d1a5c98-8169-4f40-8601-a6f6bbbbebe72024-12-09WarningsExact identifier
unii: ND2M416302
NEXXGEN 91% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC12b8c85a-da0c-47a1-9531-c9f2858c4f312024-12-09WarningsExact identifier
unii: ND2M416302
NEXXGEN 91% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLC609267da-3ee6-4bd3-aecf-610d9047774c2024-12-09WarningsExact identifier
unii: ND2M416302
Guard 2U Hand SanitizerGUARD 2U HAND SANITIZERAmerican Industries, Inc.f41cf3f4-6c6e-7354-e053-2a95a90affcc2024-12-08WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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