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 244 of 323 · 6,449 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsExact identifier
unii: 3K9958V90M
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
unii: 3K9958V90M
Sinus Congestion HeadacheANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUMLiddell Laboratories, Inc.debc7747-8664-4598-a862-e295188c4fca2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 0E53J927NA
VaccinesARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENSLiddell Laboratories, Inc.6e6e67d4-089e-4775-b4a4-5511953f6e3f2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
Hand Sanitizer Cucumber AloeORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.0588ae1b-f29a-e1b6-e063-6394a90a0de12024-11-02WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Cucumber AloeETHYL ALCOHOLWhole Foods Market, Inc.074334af-c26e-4126-e063-6394a90ae4c42024-11-02WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Orange BlossomORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.07f708d1-11c8-eb50-e063-6294a90a3a812024-11-02WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.0742f251-5fc9-c015-e063-6394a90a79b12024-11-02WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Orange BlossomETHYL ALCOHOLWhole Foods Market, Inc.07436407-7a15-7cee-e063-6294a90a96512024-11-02WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.07f7e966-e57e-dede-e063-6294a90acbf52024-11-02WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.ec8c7597-a3f1-65a8-e053-2995a90a69a12024-11-02WarningsExact identifier
unii: 3K9958V90M
Alcohol Prep PadALCOHOL PREP PADASO LLC7481bfb9-2baf-b1ec-e053-2991aa0ad2de2024-11-01WarningsExact identifier
unii: ND2M416302
B Pure Moisturizing Hand Sanitizer Coconut Lime ScentedALCOHOLFourstar Group USA, Inc2e4df751-1cbf-4128-9cb0-3d3abf394bae2024-11-01WarningsExact identifier
unii: 3K9958V90M
Alcohol Prep PadALCOHOL PREP PADASO LLCf2a41151-a807-566c-e053-2995a90af8772024-11-01WarningsExact identifier
unii: ND2M416302
B Pure Moisturizing Hand Sanitizer Hibiscus ScentedALCOHOLFourstar Group USA, Inc40cf9951-18c0-4abf-8467-d4b2f0a38adc2024-11-01WarningsExact identifier
unii: 3K9958V90M
Lemongrass Hand SanitizerALCOHOLNatural Essentials, Inc.25ca3908-24aa-5e4f-e063-6394a90a7a882024-10-31WarningsExact identifier
unii: 3K9958V90M
Sanar Naturals Decolorized IodineETHYL ALCOHOLSanvall Enterprises, Inc16c92427-84d2-cad5-e063-6394a90af4352024-10-31WarningsExact identifier
unii: 3K9958V90M
Lavender Hand SanitizerALCOHOLNatural Essentials, Inc.25cada8c-8c80-c140-e063-6294a90a33362024-10-31WarningsExact identifier
unii: 3K9958V90M
Peppermint Hand SanitizerALCOHOLNatural Essentials, Inc.25cb382a-6e66-05e6-e063-6294a90a91652024-10-31WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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