FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
69842-898
11-digit product format
698420898
Labeler code
69842
Product ID
69842-898_49ebfeb6-d3ff-4eca-a18b-6c54d6dae782
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-25
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
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
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
69842-898-01esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
69842-898-01esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE17
69842-898-02esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE27
69842-898-02esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
69842-898-03esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE37
69842-898-03esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-898-01EA - Each69842-8988e64667a-babc-428e-9cf6-7dfb750ad2dc12017-12-14
69842-898-02EA - Each69842-898c6c48ea8-9457-4855-a528-85fc5cd079aa12018-01-12
69842-898-03EA - Each69842-89891e30439-9a8d-4636-945a-f616f8d4a5a012018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-898ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [CVS PHARMACY]7Current NDC, Legacy NDC, 6 package rows20250114_6f1d75c1-3c0d-41c2-a625-1ee1bf642c32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN6f1d75c1-3c0d-41c2-a625-1ee1bf642c327
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD6f1d75c1-3c0d-41c2-a625-1ee1bf642c327
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY6f1d75c1-3c0d-41c2-a625-1ee1bf642c327
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY6f1d75c1-3c0d-41c2-a625-1ee1bf642c327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69842-898-01698420898011 BOTTLE in 1 CARTON (69842-898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-25NoNoCurrent
69842-898-02698420898022 in 1 CARTONHistorical
69842-898-03698420898033 BOTTLE in 1 CARTON (69842-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-25NoNoCurrent