FDA.reportPublic FDA data

leader esomeprazole magnesium

Product NDC
70000-0727
11-digit product format
700000727
Labeler code
70000
Product ID
70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA207193
Marketing category
ANDA
Marketing start
2025-04-02
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
leader 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
70000-0727-1leader esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
70000-0727-1leader esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE33
70000-0727-2leader esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
70000-0727-2leader esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0727LEADER ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, 4 package rows20250425_c9472b82-d345-4531-bf07-bd55c94876ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNc9472b82-d345-4531-bf07-bd55c94876ab3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDc9472b82-d345-4531-bf07-bd55c94876ab3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYc9472b82-d345-4531-bf07-bd55c94876ab3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYc9472b82-d345-4531-bf07-bd55c94876ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0727-1700000727013 BOTTLE in 1 CARTON (70000-0727-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2025-04-23NoNoCurrent
70000-0727-2700000727021 BOTTLE in 1 CARTON (70000-0727-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2025-04-02NoNoCurrent