FDA.reportPublic FDA data

Nexium 24HR

Product NDC
50090-1492
11-digit product format
500901492
Labeler code
50090
Product ID
50090-1492_03e457d9-9b3c-435c-9b22-4b9457cc248f
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA204655
Marketing category
NDA
Marketing start
2014-05-27
Substance
ESOMEPRAZOLE MAGNESIUM
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
Nexium 24HR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726, 606728

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1492-02023-02-07C16284748780-1f386c64a-2d4c-0266-e053-dadaa90a7c1aDrug Facts
50090-1492-02023-01-30C16284748780-1f386c64a-2d4c-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1492-0Nexium 24HR3 in 1 CARTONCAPSULE, DELAYED RELEASE320
50090-1492-0Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1420

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1492-0EA - Each50090-149244e0c549-10c4-4bd0-9e8a-075e2ac63d8812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1492NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 2 package rows20240518_d56b330a-4355-4636-9d26-c592f67cea56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNd56b330a-4355-4636-9d26-c592f67cea5620
606728NexIUM 20 MG Delayed Release Oral CapsulePSNd56b330a-4355-4636-9d26-c592f67cea5620
606728esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]SBDd56b330a-4355-4636-9d26-c592f67cea5620
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDd56b330a-4355-4636-9d26-c592f67cea5620
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYd56b330a-4355-4636-9d26-c592f67cea5620
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYd56b330a-4355-4636-9d26-c592f67cea5620
606728Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral CapsuleSYd56b330a-4355-4636-9d26-c592f67cea5620
606728Nexium 20 MG Delayed Release Oral CapsuleSYd56b330a-4355-4636-9d26-c592f67cea5620
606728Nexium 24 HR 20 MG Delayed release Oral CapsuleSYd56b330a-4355-4636-9d26-c592f67cea5620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1492-0500901492003 BOTTLE in 1 CARTON (50090-1492-0) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2014-12-040000-00-00NoNoCurrent