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 300 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25TITANIUM DIOXIDE, ZINC OXIDECLINIQUE LABORATORIES LLC884abba1-891d-4c3c-b203-38a5a8a577562023-10-19WarningsExact identifier
unii: 15FIX9V2JP
Brompton and Langley Moisturizing Hand Sanitizer Lavnder VanillaALCOHOLGanzhou Olivee Cosmetic Co., Ltd.90bd3436-a8bc-4c19-a300-d59236a8de272023-10-19WarningsExact identifier
unii: 3K9958V90M
Up and Up 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTarget Corporationbecc8fe3-eaf5-4429-b462-a87dd09c4db82023-10-17WarningsExact identifier
unii: ND2M416302
Decon Hand Instant Hand SanitizerALCOHOLVeltek Associates, Inc.b0fb3d45-a5c9-4d3c-a840-1b7564ecb3f82023-10-15WarningsExact identifier
unii: 3K9958V90M
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
unii: 3K9958V90M
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.ff999b50-0b6b-404e-b4f1-c6694fe47a9b2023-10-13WarningsExact identifier
unii: ND2M416302
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar SmartOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC3d23406b-5252-4ab0-b666-77c0132b0d002023-10-13WarningsExact identifier
unii: 15FIX9V2JP
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGYOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCe557e7f3-1fa7-4dde-977f-fe3f942496c02023-10-13WarningsExact identifier
unii: 15FIX9V2JP
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC68cfcbc2-a214-437e-9956-f77c90d748882023-10-13WarningsExact identifier
unii: 15FIX9V2JP
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC159410d4-4479-4442-b371-bde72aae3e1e2023-10-13WarningsExact identifier
unii: 15FIX9V2JP
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.db61e7fd-c421-4e3c-bc88-0343230273de2023-10-13WarningsExact identifier
unii: ND2M416302
GoodSense Alcohol SwabsISOPROPYL ALCOHOLGeiss, Destin and Dunn968bab9f-5b74-270b-e053-2995a90a0df42023-10-13WarningsExact identifier
unii: ND2M416302
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
unii: 3K9958V90M
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
unii: ND2M416302
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-ProtectionHOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDELaboratoires Clarins0695e3a4-0e8f-419e-b128-9b02bdb8b02a2023-10-11WarningsExact identifier
unii: 15FIX9V2JP
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: ETJ7Z6XBU4
BB Broad Spectrum SPF 15 LightZINC OXIDE TITANIUM DIOXIDEBurt's Bees3150ef71-2ea1-25d0-e054-00144ff88e882023-10-05WarningsExact identifier
unii: 15FIX9V2JP
BB Broad Spectrum SPF 15 MediumZINC OXIDE TITANIUM DIOXIDEBurt's Bees3346f41e-32d0-35d0-e054-00144ff88e882023-10-05WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATIONOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC4c40047b-01d6-4221-a044-9f884519bdd52023-10-05WarningsExact identifier
unii: 15FIX9V2JP
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC756cb656-2f79-4e7f-b4b3-18d6e89309212023-10-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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