FDA.reportPublic FDA data

Esomeprazole Magnesium Delayed Release

Product NDC
0363-7810
11-digit product format
003637810
Labeler code
0363
Product ID
0363-7810_3347c9eb-2f69-d5b6-e063-6394a90aea81
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
WALGREENS
Application
ANDA217264
Marketing category
ANDA
Marketing start
2025-06-03
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 Magnesium Delayed Release
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
0363-7810-41Esomeprazole Magnesium Delayed Release14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
0363-7810-41Esomeprazole Magnesium Delayed Release3 in 1 CARTONCAPSULE, DELAYED RELEASE32
0363-7810-45Esomeprazole Magnesium Delayed Release14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
0363-7810-45Esomeprazole Magnesium Delayed Release1 in 1 CARTONCAPSULE, DELAYED RELEASE12
0363-7810-82Esomeprazole Magnesium Delayed Release14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
0363-7810-82Esomeprazole Magnesium Delayed Release2 in 1 CARTONCAPSULE, DELAYED RELEASE22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2fa5d747-a014-2475-e063-6294a90ab9182
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2fa5d747-a014-2475-e063-6294a90ab9182
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2fa5d747-a014-2475-e063-6294a90ab9182
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2fa5d747-a014-2475-e063-6294a90ab9182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-7810-41003637810413 BOTTLE in 1 CARTON (0363-7810-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2025-06-03NoNoCurrent
0363-7810-45003637810451 BOTTLE in 1 CARTON (0363-7810-45) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2025-06-03NoNoCurrent
0363-7810-82003637810822 BOTTLE in 1 CARTON (0363-7810-82) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2025-06-03NoNoCurrent