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 113 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protecting FHSALCOHOLEcolab50d1e501-c143-4446-84e7-7f3f278166af2025-12-30WarningsExact identifier
unii: 3K9958V90M
Facilipro Protecting FHSALCOHOLEcolabd6fccda4-f565-406b-aeb6-585b59bddf512025-12-30WarningsExact identifier
unii: 3K9958V90M
Retail Hand SanitizerALCOHOLEcolab Inc.55e65545-9869-413b-8239-bd2d43fe36d82025-12-30WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
unii: 3K9958V90M
Refreshify Antiseptic Hand WipesALCOHOLEmes Commerce Group Inc.46d2f10e-e1c2-3ca2-e063-6394a90a602d2025-12-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.4711fb91-8afd-e5db-e063-6394a90a4b9e2025-12-29WarningsExact identifier
unii: 3K9958V90M
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
unii: 15FIX9V2JP
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
unii: 3K9958V90M
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
unii: 3K9958V90M
OI LIN SUNMILK SUNSCREEN SPF 30SUNSCREEN, TITANIUM DIOXIDESunrider Manufacturing L.P.26b57314-1616-4ca4-b65f-a363c525b4322025-12-29WarningsExact identifier
unii: 15FIX9V2JP
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Dehydrated AlcoholALCOHOLAjenat Pharmaceuticals LLC636d6421-cadf-42b3-a431-ba40c06e36d22025-12-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact identifier
unii: ND2M416302
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PISTACHIO MATCHA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limiteddfd59d2e-9036-486a-b25b-7e5fe23421ce2025-12-26WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHANOLZep Inc.c72cf71f-e639-2854-e053-2a95a90ab30e2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Handstand Instant Hand SanitizerETHYL ALCOHOLZep Inc.9984beca-a66a-785c-e053-2995a90ae5ba2025-12-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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