FDA.reportPublic FDA data

esomeprazole

Product NDC
30142-989
11-digit product format
301420989
Labeler code
30142
Product ID
30142-989_d1f98f06-8779-4753-af5f-b45fffea3d92
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
THE KROGER COMPANY
Application
ANDA212866
Marketing category
ANDA
Marketing start
2020-08-07
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
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
30142-989-14esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
30142-989-28esomeprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-989ESOMEPRAZOLE CAPSULE, DELAYED RELEASE [THE KROGER COMPANY]3Current NDC, Legacy NDC, 2 package rows20201030_7fa75bbe-5b9f-49ca-84de-f80e5a858de4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7fa75bbe-5b9f-49ca-84de-f80e5a858de43
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7fa75bbe-5b9f-49ca-84de-f80e5a858de43
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7fa75bbe-5b9f-49ca-84de-f80e5a858de43
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7fa75bbe-5b9f-49ca-84de-f80e5a858de43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-989-143014209891414 in 1 BOTTLEHistorical
30142-989-28301420989282 BOTTLE in 1 CARTON (30142-989-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (30142-989-14) 2 bottle2020-08-070000-00-00NoNoCurrent