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 166 of 324 · 6,480 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CuradISOPROPYL ALCOHOLMedline Industries, LPc42de981-4e3f-1ac9-e053-2995a90aea982025-10-09WarningsExact identifier
unii: ND2M416302
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
STERILE ALCOHOL PREP PADS 01ISOPROPYL ALCOHOLTotal Resources International Inc.efd1b423-c5f5-0677-e053-2a95a90a23eb2025-10-09WarningsExact identifier
unii: ND2M416302
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
HAND SANITIZER CHERRY ON TOPETHYL ALCOHOLPearl World Inc.218fc79e-5a57-4561-9986-f723dc12928d2025-10-09WarningsExact identifier
unii: 3K9958V90M
DigiSanALCOHOLEcolab Inc.aa921967-cd15-4bc2-9452-7637462747022025-10-09WarningsExact identifier
unii: 3K9958V90M
365 Spiced Balsam Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10cd38f9-dbe0-8bea-e063-6294a90a39872025-10-08WarningsExact identifier
unii: 3K9958V90M
365 Winterberry Saffron Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10bc43da-460a-d30d-e063-6294a90a49402025-10-08WarningsExact identifier
unii: 3K9958V90M
365 Spiced Citrus Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10d096e7-3fb9-6122-e063-6294a90a20c02025-10-08WarningsExact identifier
unii: 3K9958V90M
North Woods Derma Gel ClearALCOHOLSuperior Chemical Corporationabbd099a-8d89-80a0-e053-2a95a90a24fc2025-10-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
unii: 3K9958V90M
Novo Foaming Instant Hand SanitizerETHYL ALCOHOLNoble Chemical Inc.0f126636-9606-3aea-e063-6294a90ae3c62025-10-08WarningsExact identifier
unii: 3K9958V90M
Reddy Lab Advanced Alcohol Gel SanitizerALCOHOLFlavor Reddy Foods, LLCb9f76aec-d052-69d2-e053-2995a90a277f2025-10-08WarningsExact identifier
unii: 3K9958V90M
PurPrepPOVIDONE IODINE AND ISOPROPYL ALCOHOLCareFusion 213 LLCa1c6e118-7861-c8d0-e053-2995a90aeaaa2025-10-08WarningsExact identifier
unii: ND2M416302
MediChoice Instant Hand Sanitizer Honey scentedALCOHOLO&M HALYARD, INC.531dcfea-09d6-40d6-93e1-65dc4c79709d2025-10-08WarningsExact identifier
unii: 3K9958V90M
MediChoice Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLO&M HALYARD, INC.8b84c8ed-040e-4c07-94cb-d5bdda7446482025-10-08WarningsExact identifier
unii: ND2M416302
MediChoice Instant Hand Sanitizer Fragrance freeALCOHOLO&M HALYARD, INC.c9cd6726-8a3a-429e-bef4-e0614b7540eb2025-10-08WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand RubALCOHOLO&M HALYARD, INC.61dbc28c-6011-44a8-983d-0f6f2fe8d7622025-10-08WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER SWEET STRAWBERRYETHYL ALCOHOLPearl World Inc.cf4f279d-d61c-43c7-a6f0-fe1aeac9c0762025-10-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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