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 38 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOUNTAIN DEW HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e7850-248f-dbc2-e063-6394a90a9cfd2026-06-01WarningsExact identifier
unii: 3K9958V90M
CORE RED HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e7850-2492-dbc2-e063-6394a90a9cfd2026-06-01WarningsExact identifier
unii: 3K9958V90M
PEPSI HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd552e9e41-0573-94da-e063-6294a90aa8ec2026-06-01WarningsExact identifier
unii: 3K9958V90M
vanilla sugar hand sanitizer gelALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd567c99e6-3bc8-0600-e063-6294a90a94c92026-06-01WarningsExact identifier
unii: 3K9958V90M
very berry hand sanitizer gelALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd567d6ce2-59fa-01ae-e063-6394a90a9e782026-06-01WarningsExact identifier
unii: 3K9958V90M
Esomeprazole Magnesium Delayed-Release 20 mg (OTC)ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC)MARKSANS PHARMA LIMITED6a21f085-b60b-49b7-8098-99ccdc43dde32026-06-01WarningsExact identifier
rxcui: 606726
Smart Care WHISPERING WOODS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.dce079a4-3984-4258-82f8-7e90da31e12c2026-05-29WarningsExact identifier
unii: 3K9958V90M
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
ProCure Foaming Hand SanitizerETHYL ALCOHOL 72%Twin Med LLC3d848ec8-5197-6d39-e063-6394a90aaef62026-05-29WarningsExact identifier
unii: 3K9958V90M
Smart Care MEADOW MIRAGE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3157d8d9-35ac-4157-b97d-4cc2b6bd812e2026-05-29WarningsExact identifier
unii: 3K9958V90M
Smart Care MIDNIGHT MUSK HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4a9d80b7-619a-4eba-9535-ea7605b6cd712026-05-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.52db71d5-42fc-c3b6-e063-6394a90aea152026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Creamy Macadamia ScentedALCOHOLFourstar Group USA, Inc.e59282f1-82f1-465e-9db3-f207177151e62026-05-28WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLHubei Fanjian Medical Product Co.,Ltd9b4014a3-6296-4628-9cc6-b8d4ef4a25f32026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Midnight Freesia ScentedALCOHOLFourstar Group USA, Inc.e145d190-5290-47d9-9961-e35f746e6b5a2026-05-28WarningsExact identifier
unii: 3K9958V90M
Alcohol Cleansing WipeALCOHOLHubei Fanjian Medical Product Co.,Ltdf278a911-ac4e-6868-e053-2a95a90a2ee32026-05-28WarningsExact identifier
unii: 3K9958V90M
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Warm DriftwoodALCOHOLMy Imports Usa, LLCb8457e01-e95f-4507-ac83-3c537c4677392026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer White MuskALCOHOLMy Imports Usa, LLCee41e0d2-7109-4423-82db-2c751de6a5d82026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Caramel CinnamonALCOHOLMy Imports Usa, LLCa77a074b-662a-4d40-a73e-6fe215d2c22f2026-05-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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