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 275 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS IodineIODINE, SODIUM IODIDE AND ALCOHOLCVS Pharmacyb11db4e5-6a6d-4d4a-b980-600692b541762023-12-20WarningsExact identifier
unii: 3K9958V90M
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact identifier
unii: 15FIX9V2JP
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc2023-12-20WarningsExact identifier
unii: 15FIX9V2JP
Sanitizing wipes with aloe Grapefruit GroveALCOHOLThe Honest Companyfaa3690b-ce0d-43d4-9e5c-f2ce77daabe72023-12-19WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes Fragrance FreeALCOHOLThe Honest Company0ce3e7ee-aa50-16bc-e063-6294a90a527d2023-12-19WarningsExact identifier
unii: 3K9958V90M
sunmark Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC46da2750-37d1-4ed1-baf3-1fd4266175672023-12-19WarningsExact identifier
unii: ND2M416302
Sunmark IodineIODINE, SODIUM IODIDE, ALCOHOLStrategic Sourcing Services LLCe8dae2d6-58b1-4c4e-a4c1-371db055b7ae2023-12-19WarningsExact identifier
unii: 3K9958V90M
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLStrategic Sourcing Services LLC515dd733-1b44-4df0-928f-a3b202b5f9c22023-12-19WarningsExact identifier
unii: ND2M416302
Sunmark Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLC92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e2023-12-19WarningsExact identifier
unii: ND2M416302
Sunmark Iodides TinctureETHYL ALCOHOLStrategic Sourcing Services LLC5e227f79-fca7-4633-97ea-61da4060fe922023-12-19WarningsExact identifier
unii: 3K9958V90M
DDM Ear Drops for SwimmersISOPROPYL ALCOHOLDiscount Drug Mart5d565cbc-874b-41dc-e053-2991aa0a67872023-12-19WarningsExact identifier
unii: ND2M416302
DDM Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLDiscount Drug Mart5d538c8e-bf87-d85c-e053-2991aa0af7292023-12-19WarningsExact identifier
unii: 3K9958V90M
DDM Decolorized IodineETHYL ALCOHOLDiscount Drug Mart5d570ea7-ab08-54b7-e053-2991aa0a7a832023-12-19WarningsExact identifier
unii: 3K9958V90M
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutralTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.f5d54e9d-4963-419a-a091-bdbd1decd2b82023-12-19WarningsExact identifier
unii: 15FIX9V2JP
MenatrolFOLATE, MULTIVITAMINPureTek Corporation0a100e7d-3a8d-2d8b-e063-6394a90a32032023-12-18Boxed warning, Adverse reactionsExact identifier
unii: 3A3U0GI71G

Reported adverse events (FAERS/openFDA)#

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