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 71 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MediChoice Antiseptic Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.20b3694e-04c7-4bca-b2ce-62ae0dec7a832026-03-05WarningsExact identifier
unii: ND2M416302
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7f78529d-df17-44b3-a890-1afa35308c672026-03-05WarningsExact identifier
unii: ND2M416302
MediChoice Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.f4f54448-0de0-448c-9b7b-104370953ae52026-03-05WarningsExact identifier
unii: ND2M416302
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7cee1141-4a49-4fec-a627-91a88e3d3ffc2026-03-05WarningsExact identifier
unii: ND2M416302
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
SPA HAND SANITIZER WRTER MELON SPLASHETHYL ALCOHOLRejoice International Corp.4c53620d-01ee-8ddd-e063-6294a90a8a2b2026-03-05WarningsExact identifier
unii: 3K9958V90M
Smart Care PISTACHIO CREME HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e763a268-b8d0-4237-bf8e-28433c0e80b22026-03-05WarningsExact identifier
unii: 3K9958V90M
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
SSDC Gel Hand SanitizerALCOHOLEcolab Inc.56fd749e-67d2-4d6f-b681-c0a44db9eef32026-03-04WarningsExact identifier
unii: 3K9958V90M
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Hand SanitizerALCOHOLTrifecta Pharmaceuticals USA0ba469a8-53f3-eb8e-e063-6294a90a1efc2026-03-04WarningsExact identifier
unii: 3K9958V90M
Avant Foaming Hand SanitizerALCOHOLB4 Soap LLC6cc57ff1-e49b-4c15-b997-886a29d3fe1c2026-03-04WarningsExact identifier
unii: 3K9958V90M
Ear RingingARNICA MONTANA, CALCAREA CARBONICA, CHENOPODIUM ANTH, CHININUM SALICYLICUM, CIMICIFUGA RACEMOSA, COFFEA TOSTA, KALI IODATUM, KALMIA LATIFOLIA, MAGNESIA CARBONICA, MANGANUM ACETICUM, MANGANUM CARBONICUM, MERCURIUS VIVUS, NATRUM SALICYLICUM, SALICYLICUM ACIDUM, THIOSINAMINUM, AND THYROIDINUM.King Bio Inc.4227b9a3-b0c1-4c74-9edd-922e32e6e89d2026-03-04WarningsExact identifier
unii: 0E53J927NA
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Isopropyl alcohol 91 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCa6d2068f-705d-4341-b1c8-81e1b563ab9a2026-03-04WarningsExact identifier
unii: ND2M416302
Smart Care FRENCH VANILLA HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.047f107b-c4d7-42d4-9c9c-5af8280be7582026-03-04WarningsExact identifier
unii: 3K9958V90M
Everyone Hand Sanitizer Lavender AloeALCOHOLEO Products, LLCd15c1fb9-b25b-45b8-a119-ee4c86c8d91c2026-03-03WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLAmazon.Com Services LLC85421e9a-f1c9-4793-9479-8a072a610ed72026-03-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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