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 290 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLA-S Medication Solutionsb44b07a0-91ff-476a-ae0a-080fa01917772023-10-31WarningsExact identifier
unii: ND2M416302
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact identifier
unii: 15FIX9V2JP
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
unii: 15FIX9V2JP
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb9829141-8222-3381-e053-2995a90ac0332023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic 1 GALLON HAND SANITIZERALCOHOLCleanGenic, LLCb982987b-c462-1ade-e053-2995a90ae6f72023-10-28WarningsExact identifier
unii: 3K9958V90M
Foaming Alcohol Hand SanitizerALCOHOLSimoniz USA, Incd8925e9b-dd6e-4fad-aa3f-ae8fb895f2e12023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic 8 OZ HAND SANITIZERALCOHOLCleanGenic, LLCb9828dd7-63a1-0bf4-e053-2a95a90a45692023-10-28WarningsExact identifier
unii: 3K9958V90M
Simple Hygiene foaming hand Sanitizer 62ALCOHOLFULLER INDUSTRIES, INC64ceef51-78a6-4beb-a0aa-d4d5f9a0d84e2023-10-28WarningsExact identifier
unii: 3K9958V90M
Simple Hygiene Hand SanitizerALCOHOLFULLER INDUSTRIES, INCf2a4bdd0-f78b-4a62-b2d3-bb78e57886002023-10-28WarningsExact identifier
unii: 3K9958V90M
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb982b2ed-6565-326a-e053-2a95a90a72d22023-10-28WarningsExact identifier
unii: 3K9958V90M
Instant Sanitizing GelALCOHOLSORA KOZMETIK SANAYI TICARET ANONIM SIRKETIadc84467-6c70-0246-e053-2995a90ac4e72023-10-28WarningsExact identifier
unii: 3K9958V90M
Hygienic Instant Hand Sanitizing WipesALCOHOLSORA KOZMETIK SANAYI TICARET ANONIM SIRKETIadc7d12d-f746-140a-e053-2a95a90a90b02023-10-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizing GelALCOHOLSORA KOZMETIK SANAYI TICARET ANONIM SIRKETIadc83823-a3b0-41b7-e053-2995a90a0de82023-10-28WarningsExact identifier
unii: 3K9958V90M
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
unii: ND2M416302
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
unii: 15FIX9V2JP
bubble gum scent hand sanitizerALCOHOLK7 DESIGN GROUP INCc280949b-fe20-4bad-b8f5-018a01340f752023-10-26WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLK7 Design Group Inc.a4e65bc9-3a84-142c-e053-2995a90ade6a2023-10-26WarningsExact identifier
unii: 3K9958V90M
PARASOL HAND SANITIZERALCOHOLWe've Got Chemistry LLCd06d1487-85a3-4e06-8532-75b825a498d42023-10-26WarningsExact identifier
unii: 3K9958V90M
citrus crush scent hand sanitizer pandaALCOHOLK7 DESIGN GROUP INC9fb73aef-3eb3-4c3e-81cb-1d56fcd95a0b2023-10-26WarningsExact identifier
unii: 3K9958V90M
JUSTICE 194011 HEART IT ANTIBAC BLACKBERRY AND VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZERALCOHOLTween Brands, Inc.7695037a-5dfa-43f3-afd5-aa79a7a9dd7e2023-10-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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