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 281 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unscented Hand SanitizerALCOHOLRaining Rosef706620b-15b3-4468-e053-6394a90a83172023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef7070892-741f-e528-e053-6294a90aee7a2023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef707644e-aa2c-d80a-e053-6394a90a33312023-11-30WarningsExact identifier
unii: 3K9958V90M
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
unii: 15FIX9V2JP
Coconut Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.95d41ada-68fc-44bf-bf34-1904d5b0dc452023-11-29WarningsExact identifier
unii: 3K9958V90M
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
unii: 0E53J927NA
Natural Extensions Fragrance- Free Instant Hand SanitizerALCOHOLBenco Dentalb1f10f16-8269-402a-9646-32dbfdef1ffc2023-11-28WarningsExact identifier
unii: 3K9958V90M
Zogics Instant Hand Sanitizer Hydrating GelALCOHOLZogics, LLC29c5f277-7b8a-4f38-8a09-33139f27c9102023-11-28WarningsExact identifier
unii: 3K9958V90M
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMTIME CAP LABORATORIES, INC.08acf79f-f50d-8416-e063-6294a90a27042023-11-23WarningsExact identifier
rxcui: 606726
Alcohol WipesALCOHOLShaoxing Elite Bio-Tech Co.,Ltd.b42c2735-ead2-4db9-e053-2a95a90a229f2023-11-22WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Vampire BloodALCOHOLBath & Body Works, Inc.0aac0b96-e477-173c-e063-6294a90a9a162023-11-21WarningsExact identifier
unii: 3K9958V90M
B-Pure Coconut Scented Hand SanitizingALCOHOLFourstar Group USA, Inc.52b21789-d544-451e-b54a-4e2b4b85f4452023-11-21WarningsExact identifier
unii: 3K9958V90M
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.c82c37d7-d8fd-4411-a18f-fab4d1eaa2a92023-11-21WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLHit Promotional Productsa410e8a6-5c68-4358-a6ce-77d7a99ace792023-11-21WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.125fdc7c-fea3-4ced-8df2-0d35877df62d2023-11-21WarningsExact identifier
unii: 3K9958V90M
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBETTER LIVING BRANDS, LLCeb4c1cac-89a2-c040-e053-2995a90ae1cd2023-11-17WarningsExact identifier
rxcui: 606726
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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