FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
72559-011
11-digit product format
725590011
Labeler code
72559
Product ID
72559-011_1b1a0d42-2f12-fb82-e063-6394a90af12f
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
LITTLE PHARMA, INC.
Application
ANDA212866
Marketing category
ANDA
Marketing start
2021-03-23
Substance
ESOMEPRAZOLE MAGNESIUM
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 MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
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
72559-011-06Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE37
72559-011-06Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
72559-011-07Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
72559-011-36Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE37
72559-011-36Esomeprazole Magnesium4 in 1 PACKAGE, COMBINATIONCAPSULE, DELAYED RELEASE47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-011ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [LITTLE PHARMA, INC.]7Current NDC, Legacy NDC, 5 package rows20240619_e45621ea-cc15-4a8e-98d2-d10ab424a45e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe45621ea-cc15-4a8e-98d2-d10ab424a45e7
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe45621ea-cc15-4a8e-98d2-d10ab424a45e7
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe45621ea-cc15-4a8e-98d2-d10ab424a45e7
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe45621ea-cc15-4a8e-98d2-d10ab424a45e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72559-011-06725590011063 BOTTLE in 1 CARTON (72559-011-06) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-03-230000-00-00NoNoCurrent
72559-011-077255900110714 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72559-011-07) 2021-03-230000-00-00NoNoCurrent
72559-011-36725590011364 CARTON in 1 PACKAGE, COMBINATION (72559-011-36) / 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE4 carton2024-06-18NoNoCurrent