Nexium 24HR

Product NDC: 50090-1461
11-digit product format: 500901461
Labeler code: 50090
Product ID: 50090-1461_9494990a-afce-41c6-9f3a-061e23b4174a
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
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 product	product	50090-1461		D	Discontinued by firm		2026-08-17
excluded package	package	50090-1461	50090-1461-0	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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1461-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1461-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1461-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1461-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1461-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1461-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1461-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1461-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1461-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-1461-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1461-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1461-0	`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
N204655-001	NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2014-03-28

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	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`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	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	d56b330a-4355-4636-9d26-c592f67cea56	2024-05-14	Warnings	Exact identifier application applno (NDA): 204655 application number: NDA204655
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	Haleon US Holdings LLC	4513934d-0cf0-40fc-a348-b4e75a33b094	2024-03-19	Warnings	Exact identifier application applno (NDA): 204655 application number: NDA204655