esomeprazole magnesium

Product NDC
42507-898
11-digit product format
425070898
Labeler code
42507
Product ID
42507-898_320a5a94-ab7d-4d44-9201-b73e7aab50e5
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
HyVee Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2026-01-28
Substance
ESOMEPRAZOLE
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
esomeprazole magnesium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
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
42507-898-00esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
42507-898-42esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb0968243-171e-428a-b692-740e0c05a0fc2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb0968243-171e-428a-b692-740e0c05a0fc2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb0968243-171e-428a-b692-740e0c05a0fc2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb0968243-171e-428a-b692-740e0c05a0fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-898-004250708980014 in 1 BOTTLEHistorical
42507-898-42425070898423 BOTTLE in 1 CARTON (42507-898-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42507-898-00) 3 bottle2026-01-28NoNoHistorical