FDA.reportPublic FDA data

Esomeprazole

Product NDC
21130-926
11-digit product format
211300926
Labeler code
21130
Product ID
21130-926_8b9a5e10-02a5-4a3d-a4c2-83ca4e47c02d
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Safeway, Inc.
Application
ANDA212866
Marketing category
ANDA
Marketing start
2022-12-07
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
21130-926-14Esomeprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE12
21130-926-14Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-926-28Esomeprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE22
21130-926-28Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-926-42Esomeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE32
21130-926-42Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-926ESOMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2Current NDC, 6 package rows20230830_7c497204-29ce-45e0-84d4-91b981c9b7aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7c497204-29ce-45e0-84d4-91b981c9b7aa2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7c497204-29ce-45e0-84d4-91b981c9b7aa2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7c497204-29ce-45e0-84d4-91b981c9b7aa2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7c497204-29ce-45e0-84d4-91b981c9b7aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-926-14211300926141 BOTTLE in 1 CARTON (21130-926-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-12-07NoNoHistorical
21130-926-28211300926282 BOTTLE in 1 CARTON (21130-926-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-12-07NoNoHistorical
21130-926-42211300926423 BOTTLE in 1 CARTON (21130-926-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-12-07NoNoHistorical