FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
70000-0695
11-digit product format
700000695
Labeler code
70000
Product ID
70000-0695_90df7bbb-c55e-4a01-90b7-c118b65617a9
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA214473
Marketing category
ANDA
Marketing start
2024-06-27
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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 MAGNESIUM DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui433733

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
70000-0695-1Esomeprazole Magnesium1 in 1 CARTONTABLET, DELAYED RELEASE11
70000-0695-1Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141
70000-0695-2Esomeprazole Magnesium3 in 1 CARTONTABLET, DELAYED RELEASE31
70000-0695-2Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0695ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]1Current NDC, 4 package rows20240702_90df7bbb-c55e-4a01-90b7-c118b65617a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN90df7bbb-c55e-4a01-90b7-c118b65617a91
433733esomeprazole 20 MG Delayed Release Oral TabletSCD90df7bbb-c55e-4a01-90b7-c118b65617a91
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY90df7bbb-c55e-4a01-90b7-c118b65617a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0695-1700000695011 BOTTLE in 1 CARTON (70000-0695-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2024-06-27NoNoCurrent
70000-0695-2700000695023 BOTTLE in 1 CARTON (70000-0695-2) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2024-06-27NoNoCurrent