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 190 of 324 · 6,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Travel Wipes Moisturizer and fragranceALCOHOLSINGULAR ENTERPRISES LLC46024d13-84dd-47a9-af76-d2feba62448c2025-06-06WarningsExact identifier
unii: 3K9958V90M
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
unii: 15FIX9V2JP
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
unii: 15FIX9V2JP
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Hand Sanitizer WipesALCOHOLSouthern Telecom, Inc.a6d06b25-735a-73c1-e053-2995a90a8b3c2025-06-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hibiscus HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.78fca09a-b4be-408b-b6e2-23df558e76702025-06-05WarningsExact identifier
unii: 3K9958V90M
The Pharma-C Company 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLKleen Test Products Corporationa0f93dac-7baa-4f79-b6a0-3cabe52806bb2025-06-04WarningsExact identifier
unii: ND2M416302
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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