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 101 of 328 · 6,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus Drops 5027THYMUS DROPSProfessional Complementary Health Formulas8d7c42f7-02ae-4992-986f-4743151ad3bb2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rose Quartz 8142ROSE QUARTZProfessional Complementary Health Formulas898cd57d-8656-457d-92ff-5b4ea13578002026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Spleen/Pancreas 7002RET SPLEEN/PANCREASProfessional Complementary Health Formulasc6c82d50-0650-4cd9-85b9-c3cd422a35ce2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: 5138Q19F1X
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
unii: 3K9958V90M
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
unii: ND2M416302
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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