Esomeprazole

Product NDC
72036-982
11-digit product format
720360982
Labeler code
72036
Product ID
72036-982_97ef0c76-1b40-4263-9ec0-eba9a9f3d454
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
TABLET
Route
ORAL
Labeler
HARRIS TEETER
Application
ANDA212866
Marketing category
ANDA
Marketing start
2021-03-03
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
Rxcui433733

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
72036-982-42Esomeprazole14 in 1 BOTTLETABLET143
72036-982-42Esomeprazole3 in 1 CARTONTABLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-982ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) TABLET [HARRIS TEETER]3Current NDC, Legacy NDC, 2 package rows20210504_ea9ef7b0-7397-470f-b852-397e8b0e66e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSNea9ef7b0-7397-470f-b852-397e8b0e66e43
433733esomeprazole 20 MG Delayed Release Oral TabletSCDea9ef7b0-7397-470f-b852-397e8b0e66e43
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSYea9ef7b0-7397-470f-b852-397e8b0e66e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72036-982-42720360982423 BOTTLE in 1 CARTON (72036-982-42) / 14 TABLET in 1 BOTTLE3 bottle2021-03-030000-00-00NoNoCurrent