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 263 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caseys Antimicrobial Hand SanitizerETHYL ALCOHOLNavajo Manufacturing Company Inc.78863024-390c-4ff9-8ed6-02af07902a302024-04-29WarningsExact identifier
unii: 3K9958V90M
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacy, Inc.d226cda0-5cdb-4e2d-a865-530a8f09a0952024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMINNOVUS PHARMACEUTICALS, INC.a32039b7-8475-4ec5-abaf-07f9aee3954b2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMFamily Dollar Stores, LLCf86ba9b5-736e-b279-e053-6394a90acf7c2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAhold U.S.A., Inc,7bb719a0-9836-6752-e053-2a91aa0a2f482024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBetter Living Brands LLCee6e3f66-4eb9-4094-afcc-aaa020942b392024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBest Choice56120925-28e3-4e6c-b54d-490d7460984f2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWALGREEN CO.f9e10472-c6a3-402c-b6a2-f8700ad73e9f2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWal-Mart Stores, Inc.c14f096d-ea1f-4539-8ad0-bb9907745cfc2024-04-27WarningsExact identifier
rxcui: 606726
unii: 36H71644EQ
EcolabETHYL ALCOHOLEcolab Inc.f30e801c-d7ae-4a6f-830b-31d86c4f5b8c2024-04-26WarningsExact identifier
unii: 3K9958V90M
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
unii: ND2M416302
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TanTITANIUM DIOXIDEChantecaille Beaute Incfdf05545-5a21-4238-b0d3-e3fcdfe866ff2024-04-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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