FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
58602-809
11-digit product format
586020809
Labeler code
58602
Product ID
58602-809_2d45adc7-14a7-4377-b51d-da80f800b027
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA209339
Marketing category
ANDA
Marketing start
2017-10-16
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
20 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 DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui606726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
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
58602-809-05Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE112
58602-809-05Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1412
58602-809-61Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE212
58602-809-61Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1412
58602-809-62Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1412
58602-809-62Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-809-61EA - Each58602-809f04123c8-3bda-407a-9a56-41e5791db38112021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-809ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AUROHEALTH LLC]12Current NDC, Legacy NDC, 6 package rows20250523_b594f052-b6be-4d3b-9316-29cab050344a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb594f052-b6be-4d3b-9316-29cab050344a12
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb594f052-b6be-4d3b-9316-29cab050344a12
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb594f052-b6be-4d3b-9316-29cab050344a12
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb594f052-b6be-4d3b-9316-29cab050344a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-809-05586020809051 BOTTLE in 1 CARTON (58602-809-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-160000-00-00NoNoCurrent
58602-809-61586020809612 BOTTLE in 1 CARTON (58602-809-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-10-160000-00-00NoNoCurrent
58602-809-62586020809623 BOTTLE in 1 CARTON (58602-809-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-10-160000-00-00NoNoCurrent