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 262 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Hand SanitizerALCOHOLTekweld Solutions, Inc.f4a330af-fb95-456a-9d43-375de339d4632024-05-09WarningsExact identifier
unii: 3K9958V90M
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
unii: 15FIX9V2JP
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
unii: ND2M416302
EMF Protect and BalanceALFALFA, FUCUS VESICULOSUS, KALI PHOSPHORICUM, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, FERRUM METALLICUM, CADMIUM SULPHURATUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, YTTERBIUM OXIDE, TARENTULA CUBENSIS, X-RAY, CUPRUM METALLICUM, SILICEADeseret Biologicals, Inc.df7e925e-00d1-4b0c-8a78-ad38148bc3602024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4
Multiple MiasmARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SULPHUR, ALOE, CARCINOSIN, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Inc.0cf54ec3-d731-4f27-89fd-4571d991a6152024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVAEnergique, Inc.daf83dbf-bbf4-49e2-ade1-1d86f3e526752024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4
Occuloplex IEUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENEBioActive Nutritional, Inc.c2c9b577-4f75-4ddc-815f-46c3bb9b46d22024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 0E53J927NA
LymphoplusTRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEADeseret Biologicals, Inc.92f6fc6b-58c0-4137-88b3-bee2118aeb292024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp Incd5a842f3-d21b-4ddf-87f1-e44daf5cfe052024-05-08WarningsExact identifier
rxcui: 606726
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.a1b42f4b-4029-4008-b950-a7725f34b43d2024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
Prenatol-MMULTIVITAMINPureTek Corporation17559a44-94b7-9ca0-e063-6294a90a21232024-05-06Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.04dfad30-9496-43c6-8ce8-ab04fdb9ce3b2024-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
unii: 368GB5141J
Tork Hand Sanitizer Alcohol GelETHYL ALCOHOLEssity Professional Hygiene North America LLC9595a664-b7d5-d726-e053-2995a90a20432024-05-02WarningsExact identifier
unii: 3K9958V90M
Pacific Blue Select Gel Hand Sanitizer Fragrance and Dye FreeETHYL ALCOHOLGeorgia-Pacific Consumer Products5bb3a32b-dc2e-4d0c-8a2d-25c278097fee2024-05-02WarningsExact identifier
unii: 3K9958V90M
Pacific Blue Select Foam Hand Sanitizer, Fragrance Free, Dye FreeETHYL ALCOHOLGeorgia-Pacific Consumer Productsf5f21c28-253a-42c4-84f3-34d72f73c9ca2024-05-02WarningsExact identifier
unii: 3K9958V90M
Pacific Blue Basic Gel Hand Sanitizer with MoisturizersETHYL ALCOHOLGeorgia-Pacific Consumer Products51fa26fd-24c5-4bd4-bfe8-8d1a733f1eac2024-05-02WarningsExact identifier
unii: 3K9958V90M
AI MiasmASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMEnergique, Inc.df829e4a-c982-4d02-b318-38b1fbc5072d2024-05-02WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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