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 271 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsExact identifier
unii: 3K9958V90M
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsExact identifier
unii: 3K9958V90M
Latalia Sanitizing WipesALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDaf850b5e-c99f-3d4e-e053-2995a90a79482024-01-10WarningsExact identifier
unii: 3K9958V90M
Latalia Alcohol Antiseptic 80 SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDba4b8fb3-09db-fa29-e053-2995a90a86172024-01-10WarningsExact identifier
unii: 3K9958V90M
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
unii: 15FIX9V2JP
Alcohol Prep PadALCOHOL PREP PADBioMed Resource Inc.03be8a96-c163-0e22-e054-00144ff8d46c2024-01-10WarningsExact identifier
unii: ND2M416302
Meijer 70 Isopropyl Alcohol Wipes First Aid AntisepticISOPROPYL ALCOHOLMeijer, Inc2046162f-cb70-416c-ae37-14999883a8072024-01-09WarningsExact identifier
unii: ND2M416302
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
unii: 15FIX9V2JP
TriStart DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENTCarWin Pharmaceutical Associates, LLC92ccf7d4-4527-49f0-b890-1a11b5a100862024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMZhejiang Yongtai Pharmaceutical Co., Ltd5ea93b2b-115b-4591-97ea-311d77e3a5ba2024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
A05 HEAVY ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUMApex Energetics Inc.b9bdc39e-8ebf-615c-e053-2a95a90afe1b2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F10 WRMLVAGRIMONY, ALOE VERA, AURUM METALLICUM, AZURITE, BASIL, CALENDULA OFFICINALIS, CARICA PAPAYA, CAYENNE, DAFFODIL, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, HIBISCUS CHINENSIS, HORSE CHESTNUT, HYLOTELEPHIUM TELEPHIUM, LAVANDULA STOECHAS, LILIUM TIGRINUM, MALVA NEGLECTA, MELILOTUS ALBA, NELUMBO NUCIFERA, PHOSPHORUS, PRUNELLA VULGARIS, ROSA LUCIAE, ROSEMARY, SCUTELLARIA LATERIFLORA, SEPIA, SILICEA, THUJA OCCIDENTALIS, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, YELLOW JASMINEApex Energetics Inc.bf020c17-578d-74c4-e053-2995a90a9e7d2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N01 PROTOMERADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUMApex Energetics Inc.bfc8e049-2f62-31c4-e053-2a95a90a6e162024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F25 LF-CHNGSAGRIMONY FLOWERApex Energetics Inc.bf3c7a21-0e4e-6395-e053-2a95a90a71562024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
R16 BRONCHIADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.c0f759b1-d7f8-12b3-e053-2a95a90a87682024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N09 BACTEROTOXACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.ba99bb1e-c36f-8bf8-e053-2995a90ac3082024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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