FDA.reportPublic FDA data

kirkland signature esomeprazole magnesium

Product NDC
63981-898
11-digit product format
639810898
Labeler code
63981
Product ID
63981-898_7eb4e2fc-b372-464a-b0aa-d63d52c6717e
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-22
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
kirkland signature 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
63981-898-01kirkland signature esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
63981-898-03kirkland signature esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-898-03EA - Each63981-8986656ad49-9376-4062-9a20-f7e312e70df412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-898KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [COSTCO WHOLESALE COMPANY]6Current NDC, Legacy NDC, 2 package rows20240809_4a87d5d5-c98b-4dc5-81be-50183342b047.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN4a87d5d5-c98b-4dc5-81be-50183342b0476
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD4a87d5d5-c98b-4dc5-81be-50183342b0476
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY4a87d5d5-c98b-4dc5-81be-50183342b0476
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY4a87d5d5-c98b-4dc5-81be-50183342b0476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-898-016398108980114 in 1 BOTTLEHistorical
63981-898-03639810898033 BOTTLE in 1 CARTON (63981-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63981-898-01) 3 bottle2017-09-220000-00-00NoNoCurrent