FDA.reportPublic FDA data

Esomeprazole

Product NDC
73581-013
11-digit product format
735810013
Labeler code
73581
Product ID
73581-013_43f3c680-d4a7-5094-e063-6394a90a6ef0
Type
HUMAN OTC DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
YYBA CORP
Application
ANDA212866
Marketing category
ANDA
Marketing start
2023-03-08
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
73581-013-42Esomeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33
73581-013-42Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-013ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [YYBA CORP]2Current NDC, 2 package rows20230914_0912d311-e26c-479d-9f13-ef0ac403e9b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN0912d311-e26c-479d-9f13-ef0ac403e9b83
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD0912d311-e26c-479d-9f13-ef0ac403e9b83
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY0912d311-e26c-479d-9f13-ef0ac403e9b83
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY0912d311-e26c-479d-9f13-ef0ac403e9b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73581-013-42735810013423 BOTTLE in 1 CARTON (73581-013-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-03-08NoNoCurrent