FDA.reportPublic FDA data

Esomeprazole

Product NDC
51316-715
11-digit product format
513160715
Labeler code
51316
Product ID
51316-715_3ed41fde-979d-6204-e063-6394a90ad1c1
Type
HUMAN OTC DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS
Application
ANDA212866
Marketing category
ANDA
Marketing start
2022-09-02
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
51316-715-14Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
51316-715-14Esomeprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE13
51316-715-28Esomeprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE23
51316-715-28Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
51316-715-42Esomeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33
51316-715-42Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-715ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CVS]2Current NDC, Legacy NDC, 6 package rows20221217_b68035d0-195a-41e8-9928-8b1bd57917c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb68035d0-195a-41e8-9928-8b1bd57917c03
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb68035d0-195a-41e8-9928-8b1bd57917c03
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb68035d0-195a-41e8-9928-8b1bd57917c03
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb68035d0-195a-41e8-9928-8b1bd57917c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-715-14513160715141 BOTTLE in 1 CARTON (51316-715-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-09-020000-00-00NoNoCurrent
51316-715-27513160715272 BOTTLE in 1 CARTON (51316-715-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-09-020000-00-00NoNoCurrent
51316-715-28513160715282 BOTTLE in 1 CARTON (51316-715-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-09-02NoNoHistorical
51316-715-42513160715423 BOTTLE in 1 CARTON (51316-715-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-09-02NoNoHistorical
51316-715-44513160715443 BOTTLE in 1 CARTON (51316-715-44) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-09-020000-00-00NoNoCurrent