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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0573-2451	0573-2451-28	D	Discontinued by firm		2026-08-17
excluded package	package	0573-2451	0573-2451-43	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0573-2451-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0573-2451-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0573-2451-43	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0573-2451-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0573-2451-43	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0573-2451-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0573-2451-43	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0573-2451-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0573-2451-43	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0573-2451-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0573-2451-43	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0573-2451-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0573-2451-43	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0573-2451-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0573-2451-43	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0573-2451-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0573-2451-43	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0573-2451-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0573-2451-43	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0573-2451-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0573-2451-43	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0573-2451-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0573-2451-43	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0573-2451-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207920-001	NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2015-11-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207920-001	NEXIUM 24HR	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2015-11-23	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207920-001	6428810	2019-11-03	U-1785	Drug product	2015-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207920-001	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207920-001	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207920-001	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207920-001	6428810	2019-11-03	U-1785	Drug product	2015-12-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207920-001	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207920-001	6428810	2019-11-03	U-1785	Drug product	2015-12-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207920-001	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207920-001	6428810	2019-11-03	U-1785	Drug product	2015-12-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207920-001	6428810*PED	2020-05-03		Pediatric extension		`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nexium 24HR

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R6DXU4WAY9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
433733	Internal RxNorm lookup
1743279	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
61f67858-ba2f-449b-8b30-c15cdaf49222	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	8	20171212
094c6751-235c-4d12-acee-2baf94f676f4	Product name	1	20151116
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0573-2451-14	Drug Facts
0573-2451-14	Drug Facts
0573-2451-28	Drug Facts
0573-2451-28	Drug Facts
0573-2451-42	Drug Facts
0573-2451-42	Drug Facts
0573-2451-43	Drug Facts
0573-2451-43	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-2451-14	Nexium 24HR	1 in 1 CARTON	TABLET	1	12
0573-2451-14	Nexium 24HR	14 in 1 BOTTLE	TABLET	14	12
0573-2451-28	Nexium 24HR	14 in 1 BOTTLE	TABLET	14	12
0573-2451-28	Nexium 24HR	2 in 1 CARTON	TABLET	2	12
0573-2451-42	Nexium 24HR	3 in 1 BLISTER PACK	TABLET	3	12
0573-2451-42	Nexium 24HR	14 in 1 BOTTLE	TABLET	14	12
0573-2451-43	Nexium 24HR	14 in 1 BOTTLE	TABLET	14	12
0573-2451-43	Nexium 24HR	3 in 1 PACKAGE	TABLET	3	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2451-14	EA - Each	0573-2451	665a123b-947f-4789-b55e-a6ba8f01e738	1	2016-04-04
0573-2451-42	EA - Each	0573-2451	f4b1c017-209f-4f80-95a9-2a5a09c54870	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2451	NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) TABLET [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 8 package rows	20240321_61f67858-ba2f-449b-8b30-c15cdaf49222.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	Haleon US Holdings LLC	61f67858-ba2f-449b-8b30-c15cdaf49222	2025-01-09	Warnings	Exact identifier application applno (NDA): 207920 application number: NDA207920 ndc (product): 0573-2451

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	esomeprazole magnesium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
433733	esomeprazole magnesium 20 MG Delayed Release Oral Tablet	PSN	61f67858-ba2f-449b-8b30-c15cdaf49222	12
1743279	NexIUM 20 MG Delayed Release Oral Tablet	PSN	61f67858-ba2f-449b-8b30-c15cdaf49222	12
1743279	esomeprazole 20 MG Delayed Release Oral Tablet [Nexium]	SBD	61f67858-ba2f-449b-8b30-c15cdaf49222	12
433733	esomeprazole 20 MG Delayed Release Oral Tablet	SCD	61f67858-ba2f-449b-8b30-c15cdaf49222	12
433733	esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Tablet	SY	61f67858-ba2f-449b-8b30-c15cdaf49222	12
1743279	Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Tablet	SY	61f67858-ba2f-449b-8b30-c15cdaf49222	12
1743279	Nexium 20 MG Delayed Release Oral Tablet	SY	61f67858-ba2f-449b-8b30-c15cdaf49222	12
1743279	Nexium 24 HR 20 MG Delayed Release Oral Tablet	SY	61f67858-ba2f-449b-8b30-c15cdaf49222	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2451-14	00573245114	1 BOTTLE in 1 CARTON (0573-2451-14) / 14 TABLET in 1 BOTTLE	1 bottle	2016-02-06	2027-03-31	No	No	Current
0573-2451-28	00573245128	2 BOTTLE in 1 CARTON (0573-2451-28) > 14 TABLET in 1 BOTTLE	2 bottle	2021-07-01	0000-00-00	No	No	Current
0573-2451-42	00573245142	3 BOTTLE in 1 BLISTER PACK (0573-2451-42) / 14 TABLET in 1 BOTTLE	3 bottle	2016-02-06	2027-05-31	No	No	Current
0573-2451-43	00573245143	3 BOTTLE in 1 PACKAGE (0573-2451-43) > 14 TABLET in 1 BOTTLE	3 bottle	2021-07-01	0000-00-00	No	No	Current