FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
65862-784
11-digit product format
658620784
Labeler code
65862
Product ID
65862-784_7da643d0-40fb-4ead-8d34-a95c2a8334f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205606
Marketing category
ANDA
Marketing start
2016-04-21
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui606726, 606730

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf4ae091d-9b74-4a0e-ac68-057effd91e1715
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf4ae091d-9b74-4a0e-ac68-057effd91e1715
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf4ae091d-9b74-4a0e-ac68-057effd91e1715
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf4ae091d-9b74-4a0e-ac68-057effd91e1715
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf4ae091d-9b74-4a0e-ac68-057effd91e1715
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf4ae091d-9b74-4a0e-ac68-057effd91e1715
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf4ae091d-9b74-4a0e-ac68-057effd91e1715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-784-0165862078401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-01) 2016-04-210000-00-00NoNoCurrent
65862-784-106586207841010 in 1 BLISTER PACKHistorical
65862-784-256586207842525000 CAPSULE, DELAYED RELEASE in 1 BAG (65862-784-25)21-APR-16Current
65862-784-306586207843030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-30) 2016-04-210000-00-00NoNoCurrent
65862-784-39658620784393000 CAPSULE, DELAYED RELEASE in 1 BAG (65862-784-39)21-APR-16Current
65862-784-786586207847810 BLISTER PACK in 1 CARTON (65862-784-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-784-10) 10 blister pack2016-04-210000-00-00NoNoCurrent
65862-784-906586207849090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-90) 2016-04-210000-00-00NoNoCurrent
65862-784-99658620784991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-99) 2016-04-210000-00-00NoNoCurrent