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 287 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c563e53-2246-cd57-e053-2995a90a82d72023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c5753a4-f8af-9f09-e053-2995a90ad1382023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.a29c47b9-1a99-5272-e053-2a95a90af4f62023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.50ac080f-ae60-49dd-a01f-7b9bd8ea73a82023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCa185a4b0-a5d3-2487-e053-2995a90a01d32023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERLS PROMOTIONS INC.3f8cae4e-a017-4db6-9a29-ebae65bba34c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLC1f4833c5-fcac-4c01-a5c6-e72837ca0a482023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCa185c9c8-aabe-0e63-e053-2995a90a1b1e2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCce2d6c41-9423-45bd-8cbf-6749fdbb2c9f2023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLProstock LLC9e7d7912-d594-47e9-bd8a-cc4f8ac85b2c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
unii: 15FIX9V2JP
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.5fd376ec-d58a-41e3-b974-38527d15c7a82023-11-05WarningsExact identifier
unii: ND2M416302
Hand SanitizerALCOHOLDegasa, S.A. de C.V.c93048f4-8c26-44c0-a966-7ef8662a7b312023-11-05WarningsExact identifier
unii: 3K9958V90M
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
Protec Hand Sani Gel AntibacterialALCOHOLDegasa, S.A. de C.V.78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a2023-11-05WarningsExact identifier
unii: 3K9958V90M
Degasa Hand Sanitizer Lemon Lime ScentALCOHOLDegasa, S.A. de C.V.004bfacb-f79a-4f8a-9c8d-1d6e0dde1ce52023-11-05WarningsExact identifier
unii: 3K9958V90M
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
unii: ND2M416302
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCdeee5784-c68b-4cd7-acbf-f64391a01bfc2023-11-05WarningsExact identifier
unii: 15FIX9V2JP
Iso-Quin hand sanitizerALCOHOLThe Hygenic Company, LLC.d1003c9f-a6f8-3de2-e053-2995a90a6e8a2023-11-05WarningsExact identifier
unii: 3K9958V90M
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLCcef1a926-b7d4-47d6-957d-e3092e60970c2023-11-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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