FDA.reportPublic FDA data

Nexium 24HR

Product NDC
0573-2450
11-digit product format
005732450
Labeler code
0573
Product ID
0573-2450_140967ff-7019-a38f-e063-6394a90ab708
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Haleon US Holdings LLC
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
0573-2450-022024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-142024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-152024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-172024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-282024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-422024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-432024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts
0573-2450-442024-01-30C16284748780-11030e364-ffb6-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2450-02Nexium 24HR1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2450-02Nexium 24HR2 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE230
0573-2450-14Nexium 24HR1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2450-14Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-15Nexium 24HR1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE130
0573-2450-15Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-17Nexium 24HR1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2450-17Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-28Nexium 24HR2 in 1 CARTONCAPSULE, DELAYED RELEASE230
0573-2450-28Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-42Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-42Nexium 24HR3 in 1 CARTONCAPSULE, DELAYED RELEASE330
0573-2450-43Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-43Nexium 24HR3 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE330
0573-2450-44Nexium 24HR3 in 1 CARTONCAPSULE, DELAYED RELEASE330
0573-2450-44Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2450-14EA - Each0573-2450b1dd1d1e-cc3d-4bc3-a4f8-ca291490ef7412014-06-03
0573-2450-15EA - Each0573-24506b7357ba-9d45-43d2-8d27-5d06c4aa091312015-07-20
0573-2450-28EA - Each0573-24501103a115-63d5-45d7-8ebc-0b397421929a12014-06-03
0573-2450-42EA - Each0573-2450aa4a4eb6-79d1-481a-9b2d-187f0499b35812014-07-02
0573-2450-43EA - Each0573-2450834bdac9-a121-4729-81c0-bebc94327edd12014-07-02
0573-2450-56EA - Each0573-245079d2f892-8ffd-4a87-9bc5-032d0d2bc1ef12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE MAGNESIUMACTIVE INGREDIENTR6DXU4WAY9NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
GELATININACTIVE INGREDIENT2G86QN327LNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
SUCROSEINACTIVE INGREDIENTC151H8M554NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
TALCINACTIVE INGREDIENT7SEV7J4R1UNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [PFIZER CONSUMER HEALTHCARE]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2450NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM 24HR CLEARMINIS (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [HALEON US HOLDINGS LLC]30Current NDC, Legacy NDC, 16 package rows20240321_4513934d-0cf0-40fc-a348-b4e75a33b094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN4513934d-0cf0-40fc-a348-b4e75a33b09430
606728NexIUM 20 MG Delayed Release Oral CapsulePSN4513934d-0cf0-40fc-a348-b4e75a33b09430
606728esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]SBD4513934d-0cf0-40fc-a348-b4e75a33b09430
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD4513934d-0cf0-40fc-a348-b4e75a33b09430
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY4513934d-0cf0-40fc-a348-b4e75a33b09430
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY4513934d-0cf0-40fc-a348-b4e75a33b09430
606728Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral CapsuleSY4513934d-0cf0-40fc-a348-b4e75a33b09430
606728Nexium 20 MG Delayed Release Oral CapsuleSY4513934d-0cf0-40fc-a348-b4e75a33b09430
606728Nexium 24 HR 20 MG Delayed release Oral CapsuleSY4513934d-0cf0-40fc-a348-b4e75a33b09430
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
0573-2450-02005732450021 BLISTER PACK in 1 CARTON (0573-2450-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2014-10-310000-00-00NoNoCurrent
0573-2450-14005732450141 BOTTLE in 1 CARTON (0573-2450-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2014-05-270000-00-00NoNoCurrent
0573-2450-15005732450151 BOTTLE in 1 BLISTER PACK (0573-2450-15) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2014-05-270000-00-00NoNoCurrent
0573-2450-17005732450171 BOTTLE in 1 CARTON (0573-2450-17) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2014-05-270000-00-00NoNoCurrent
0573-2450-28005732450282 BOTTLE in 1 CARTON (0573-2450-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2014-05-270000-00-00NoNoCurrent
0573-2450-42005732450423 BOTTLE in 1 CARTON (0573-2450-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2014-05-270000-00-00NoNoCurrent
0573-2450-43005732450433 BOTTLE in 1 BLISTER PACK (0573-2450-43) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2014-05-270000-00-00NoNoCurrent
0573-2450-44005732450443 BOTTLE in 1 CARTON (0573-2450-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2014-05-270000-00-00NoNoCurrent