FDA.reportPublic FDA data

Nexium 24HR

Product NDC
0573-2451
11-digit product format
005732451
Labeler code
0573
Product ID
0573-2451_9e3651ca-65ce-430f-9036-1f7e42629a79
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
TABLET
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA207920
Marketing category
NDA
Marketing start
2016-02-06
Marketing end
2027-05-31
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nexium 24HR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui433733, 1743279

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
0573-2451-142024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-142024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-282024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-282024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-422024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-422024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-432024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts
0573-2451-432024-01-30C16284748780-11030e365-09e6-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2451-14Nexium 24HR1 in 1 CARTONTABLET112
0573-2451-14Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-28Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-28Nexium 24HR2 in 1 CARTONTABLET212
0573-2451-42Nexium 24HR3 in 1 BLISTER PACKTABLET312
0573-2451-42Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-43Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-43Nexium 24HR3 in 1 PACKAGETABLET312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2451-14EA - Each0573-2451665a123b-947f-4789-b55e-a6ba8f01e73812016-04-04
0573-2451-42EA - Each0573-2451f4b1c017-209f-4f80-95a9-2a5a09c5487012016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2451NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) TABLET [HALEON US HOLDINGS LLC]11Current NDC, Legacy NDC, 8 package rows20240321_61f67858-ba2f-449b-8b30-c15cdaf49222.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN61f67858-ba2f-449b-8b30-c15cdaf4922212
1743279NexIUM 20 MG Delayed Release Oral TabletPSN61f67858-ba2f-449b-8b30-c15cdaf4922212
1743279esomeprazole 20 MG Delayed Release Oral Tablet [Nexium]SBD61f67858-ba2f-449b-8b30-c15cdaf4922212
433733esomeprazole 20 MG Delayed Release Oral TabletSCD61f67858-ba2f-449b-8b30-c15cdaf4922212
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY61f67858-ba2f-449b-8b30-c15cdaf4922212
1743279Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY61f67858-ba2f-449b-8b30-c15cdaf4922212
1743279Nexium 20 MG Delayed Release Oral TabletSY61f67858-ba2f-449b-8b30-c15cdaf4922212
1743279Nexium 24 HR 20 MG Delayed Release Oral TabletSY61f67858-ba2f-449b-8b30-c15cdaf4922212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2451-14005732451141 BOTTLE in 1 CARTON (0573-2451-14) / 14 TABLET in 1 BOTTLE1 bottle2016-02-062027-03-31NoNoCurrent
0573-2451-28005732451282 BOTTLE in 1 CARTON (0573-2451-28) > 14 TABLET in 1 BOTTLE2 bottle2021-07-010000-00-00NoNoCurrent
0573-2451-42005732451423 BOTTLE in 1 BLISTER PACK (0573-2451-42) / 14 TABLET in 1 BOTTLE3 bottle2016-02-062027-05-31NoNoCurrent
0573-2451-43005732451433 BOTTLE in 1 PACKAGE (0573-2451-43) > 14 TABLET in 1 BOTTLE3 bottle2021-07-010000-00-00NoNoCurrent