FDA.reportPublic FDA data

Exchange Select Esomeprazole Magnesium

Product NDC
55301-898
11-digit product format
553010898
Labeler code
55301
Product ID
55301-898_1ee6f7c0-dff3-4372-a901-c2adef3902b1
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Army & Air Force Exchange Service
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-12-04
Substance
ESOMEPRAZOLE
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
Exchange Select Esomeprazole Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
Rxcui606726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
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
55301-898-01Exchange Select Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
55301-898-01Exchange Select Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
55301-898-03Exchange Select Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35
55301-898-03Exchange Select Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-898EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]5Current NDC, Legacy NDC, 4 package rows20240810_5fa9089f-90d1-48b6-bb79-c6171eeeaa03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN5fa9089f-90d1-48b6-bb79-c6171eeeaa035
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD5fa9089f-90d1-48b6-bb79-c6171eeeaa035
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY5fa9089f-90d1-48b6-bb79-c6171eeeaa035
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY5fa9089f-90d1-48b6-bb79-c6171eeeaa035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-898-01553010898011 BOTTLE in 1 CARTON (55301-898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-12-040000-00-00NoNoCurrent
55301-898-03553010898033 BOTTLE in 1 CARTON (55301-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-12-040000-00-00NoNoCurrent