FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
51316-088
11-digit product format
513160088
Labeler code
51316
Product ID
51316-088_c7b8460b-d1da-41d9-b644-157718295382
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA214473
Marketing category
ANDA
Marketing start
2024-07-04
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
51316-088-01Esomeprazole Magnesium1 in 1 CARTONTABLET, DELAYED RELEASE12
51316-088-01Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE142
51316-088-05Esomeprazole Magnesium3 in 1 CARTONTABLET, DELAYED RELEASE32
51316-088-05Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-088ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [CVS PHARMACY, INC.]2Current NDC, 4 package rows20240710_1867185e-9c34-c8cc-e063-6394a90ab3b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN1867185e-9c34-c8cc-e063-6394a90ab3b12
433733esomeprazole 20 MG Delayed Release Oral TabletSCD1867185e-9c34-c8cc-e063-6394a90ab3b12
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY1867185e-9c34-c8cc-e063-6394a90ab3b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-088-01513160088011 BOTTLE in 1 CARTON (51316-088-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2024-07-04NoNoCurrent
51316-088-05513160088053 BOTTLE in 1 CARTON (51316-088-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2024-07-04NoNoCurrent