FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
79481-0411
11-digit product format
794810411
Labeler code
79481
Product ID
79481-0411_aee69f51-77b9-48c9-8de3-2aa42dc88125
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA207193
Marketing category
ANDA
Marketing start
2024-03-21
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
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
79481-0411-0esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
79481-0411-1esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
79481-0411-1esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0411ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [MEIJER, INC.]2Current NDC, 3 package rows20240407_8799c88f-dafb-4be6-b279-a54d916162fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN8799c88f-dafb-4be6-b279-a54d916162fe2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD8799c88f-dafb-4be6-b279-a54d916162fe2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY8799c88f-dafb-4be6-b279-a54d916162fe2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY8799c88f-dafb-4be6-b279-a54d916162fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0411-07948104110014 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79481-0411-0) 2024-03-21NoNoCurrent
79481-0411-1794810411013 BOTTLE in 1 CARTON (79481-0411-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-03-21NoNoCurrent