FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
56062-898
11-digit product format
560620898
Labeler code
56062
Product ID
56062-898_dd61324d-e918-43f2-8c65-ddbdf7102fee
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-29
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
56062-898-01Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
56062-898-01Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
56062-898-02Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE25
56062-898-02Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
56062-898-03Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
56062-898-03Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN60554fd6-96d5-4e73-b676-332116caa8005
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD60554fd6-96d5-4e73-b676-332116caa8005
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY60554fd6-96d5-4e73-b676-332116caa8005
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY60554fd6-96d5-4e73-b676-332116caa8005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56062-898-01560620898011 BOTTLE in 1 CARTON (56062-898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-29NoNoHistorical
56062-898-02560620898022 BOTTLE in 1 CARTON (56062-898-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-09-29NoNoHistorical
56062-898-03560620898033 BOTTLE in 1 CARTON (56062-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-29NoNoHistorical