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 80 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BCBG GENERATION HAND SANITIZER ORANGE BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO432d32fa-e3d3-4740-94f0-4a828ef5bc232026-02-13WarningsExact identifier
unii: 3K9958V90M
AdvancedETHYL ALCOHOLTopco Associates LLCfaaa3452-ef1e-47db-9978-5105de69d9812026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLTopco Associates LLC686dd9a1-13db-4a2b-ba04-492d14e81b562026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
GAVISCONALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEHaleon US Holdings LLC2d74e5bc-1f10-4fb6-9258-cd906e3600132026-02-13WarningsExact identifier
unii: 0E53J927NA
Advanced Hand SanitizerALCOHOLWakefern Food Corp.9859ef63-70a7-4986-ad22-0c1c7333c6cb2026-02-13WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLWakefern Food Corp.c441a053-d241-48b4-a33b-971b890f27402026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLWakefern Food Corp.c5dd2b25-9003-4c4b-8a86-ecf186695ce32026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
BCBG GENERATION HAND SANITIZER BERGAMOT SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOfaba4dec-67dc-4db0-a48b-e39b3edf2f992026-02-13WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA HEAVEN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.43c129d8-0ad3-4630-acd9-b604cbda36e02026-02-13WarningsExact identifier
unii: 3K9958V90M
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Hand SanitizerALCOHOLWinCo Foods, LLC5f5ee353-2387-4b15-af39-5bbe3fda4dc42026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLWinco Foods25204aac-e940-45dc-804b-81fd141449d72026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
AlcoholALCOHOLWalgreen Co.1e879904-055e-4bec-a504-3c783fc9fb242026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurohealth LLC034bcbad-f57f-4338-a193-7a5aa9f09aa62026-02-12WarningsExact identifier
unii: 36H71644EQ
Spectrum Hand SanitizerETHYL ALCOHOLMedline Industries, LP70598373-bc89-07b9-e053-2991aa0a9e9a2026-02-11WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLMedline Industries, LPf84f7050-348d-4f75-ab93-e618ff8de7902026-02-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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