FDA.reportPublic FDA data

Esomeprazole DR

Product NDC
72189-381
11-digit product format
721890381
Labeler code
72189
Product ID
72189-381_2c4cbe6c-c27c-15fe-e063-6294a90ac409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole DR
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA211977
Marketing category
ANDA
Marketing start
2022-09-13
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 DR
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
72189-381-30Esomeprazole DR30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
72189-381-60Esomeprazole DR60 in 1 BOTTLECAPSULE, DELAYED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-381-30EA - Each72189-3810d377744-d6be-428f-a342-b7ffd12dd62c12022-10-06
72189-381-60EA - Each72189-381e091dc3f-e439-4902-b847-644500b3a7da12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-381ESOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT_RX]3Current NDC, Legacy NDC, 2 package rows20250123_e8937778-8baf-05f5-e053-2995a90a3a98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe8937778-8baf-05f5-e053-2995a90a3a983
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe8937778-8baf-05f5-e053-2995a90a3a983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-381-307218903813030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-381-30) 2022-09-130000-00-00NoNoCurrent
72189-381-607218903816060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-381-60) 2022-09-13NoNoCurrent