FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
0363-3298
11-digit product format
003633298
Labeler code
0363
Product ID
0363-3298_097d5b7e-28cd-4b41-2d4c-d79d22921741
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Walgreens Company
Application
ANDA207673
Marketing category
ANDA
Marketing start
2018-12-31
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
0363-3298-01Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE311
0363-3298-01Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1411
0363-3298-14Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE111
0363-3298-14Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1411
0363-3298-28Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1411
0363-3298-28Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE211
0363-3298-42Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE311
0363-3298-42Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE1411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3298ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [WALGREENS COMPANY]10Current NDC, Legacy NDC, 8 package rows20241020_f97f8604-9f00-6ed5-ae25-fedc8cf36a5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3298-01003633298013 BOTTLE in 1 CARTON (0363-3298-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2019-12-010000-00-00NoNoCurrent
0363-3298-14003633298141 BOTTLE in 1 CARTON (0363-3298-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2018-12-310000-00-00NoNoCurrent
0363-3298-28003633298282 BOTTLE in 1 CARTON (0363-3298-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2018-12-310000-00-00NoNoCurrent
0363-3298-42003633298423 BOTTLE in 1 CARTON (0363-3298-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-12-310000-00-00NoNoCurrent