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 267 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationala339dfd9-7cb8-4198-bc2a-9759648cf34e2024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationalf15a90e2-4a1e-452a-b9ac-5eb6f7b3dc722024-02-28WarningsExact identifier
unii: 3K9958V90M
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMedsource Pharmaceuticals1278cf6f-cc7a-462b-e063-6394a90a34e52024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
Han-I-Size UnscentedALCOHOLMomar Incorporated12d843ae-8175-264d-e063-6294a90ac8c02024-02-23WarningsExact identifier
unii: 3K9958V90M
BB Tint 30 BS SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs1212448c-db88-26e6-e063-6294a90a3b9e2024-02-23WarningsExact identifier
unii: 15FIX9V2JP
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd11ef87cc-6ff6-511b-e063-6294a90a662f2024-02-21WarningsExact identifier
unii: 3K9958V90M
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLMY IMPORTS USA LLC11f19126-6abb-b14c-e063-6294a90a4e342024-02-21WarningsExact identifier
unii: 3K9958V90M
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEPHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarinsbf31d19d-9520-4ac0-a4fd-2c285545f1b82024-02-20WarningsExact identifier
unii: 15FIX9V2JP
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins2c0964cd-607c-4219-b66e-cc99ada804342024-02-20WarningsExact identifier
unii: 15FIX9V2JP
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHTHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins6259442e-0c39-4887-8083-89253b64b5ff2024-02-20WarningsExact identifier
unii: 15FIX9V2JP
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.a030afc6-9248-4e6a-a814-bd700c053e5c2024-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.11c37acc-abb8-8c38-e063-6294a90a79322024-02-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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