FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
58602-840
11-digit product format
586020840
Labeler code
58602
Product ID
58602-840_5ddd44f1-1baa-4730-b718-5d1c326ecd49
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA214473
Marketing category
ANDA
Marketing start
2023-07-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui433733

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
58602-840-05Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE143
58602-840-05Esomeprazole Magnesium1 in 1 CARTONTABLET, DELAYED RELEASE13
58602-840-61Esomeprazole Magnesium2 in 1 CARTONTABLET, DELAYED RELEASE23
58602-840-61Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE143
58602-840-62Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE143
58602-840-62Esomeprazole Magnesium3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-840ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [AUROHEALTH LLC]2Current NDC, 6 package rows20240630_034bcbad-f57f-4338-a193-7a5aa9f09aa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN034bcbad-f57f-4338-a193-7a5aa9f09aa63
433733esomeprazole 20 MG Delayed Release Oral TabletSCD034bcbad-f57f-4338-a193-7a5aa9f09aa63
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY034bcbad-f57f-4338-a193-7a5aa9f09aa63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-840-05586020840051 BOTTLE in 1 CARTON (58602-840-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2023-07-12NoNoCurrent
58602-840-61586020840612 BOTTLE in 1 CARTON (58602-840-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2023-07-12NoNoCurrent
58602-840-62586020840623 BOTTLE in 1 CARTON (58602-840-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2023-07-12NoNoCurrent