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 269 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
unii: 15FIX9V2JP
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
unii: 15FIX9V2JP
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LP7b92ac4f-50c9-4061-b4a7-535a58cea8f62024-02-01Warnings, Adverse reactionsExact identifier
rxcui: 606730
SiliceaSILICON DIOXIDESEVENE USA0805d866-ce1a-4f54-8a44-83d4902e8c0d2024-01-30WarningsExact identifier
unii: ETJ7Z6XBU4
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
unii: 15FIX9V2JP
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
unii: ND2M416302
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbf0078-3660-fe5c-e063-6394a90afc2d2024-01-25WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%V/VMidwood Brands, LLC0fc032af-26bc-0e8b-e063-6294a90a91b02024-01-25WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOLMidwood Brands, LLC0fc0bd79-ddd7-b9d1-e063-6394a90adc692024-01-25WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%V/VMidwood Brands, LLC0fc0970d-06a6-ade9-e063-6394a90ae7ff2024-01-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
unii: 3K9958V90M
SannyTize Hand SanitizerHAND SANITIZERDynarex Corporation968713a5-64d3-86fc-e053-2995a90a088a2024-01-24WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbd6962-59e6-7230-e063-6394a90afd8e2024-01-24WarningsExact identifier
unii: 3K9958V90M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
unii: ND2M416302
Hand SanitizerALCOHOLCustom Chemical Solutionsa7c07167-b27b-8217-e053-2995a90ac5412024-01-22WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOLCustom Chemicial Solutionsb10420a9-b290-4536-e053-2a95a90a99972024-01-22WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer FoamALCOHOLCustom Chemical Solutionsb0f1cb6f-0b47-7652-e053-2a95a90a7c6b2024-01-22WarningsExact identifier
unii: 3K9958V90M
Hillyard Instant Hand SanitizerETHYL ALCOHOLHillyard GMP1e4a7e50-b20a-4abe-a116-319783a52cd02024-01-18WarningsExact identifier
unii: 3K9958V90M
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: ETJ7Z6XBU4
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbeac2f5-b897-5e71-e053-2995a90a75492024-01-17WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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