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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nexium 24HR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	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
606726	Internal RxNorm lookup
606728	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
d56b330a-4355-4636-9d26-c592f67cea56	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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1492-0	2023-02-07	C162847	48780-1	f386c64a-2d4c-0266-e053-dadaa90a7c1a	Drug Facts
50090-1492-0	2023-01-30	C162847	48780-1	f386c64a-2d4c-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1492-0	Nexium 24HR	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3		20
50090-1492-0	Nexium 24HR	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1492-0	EA - Each	50090-1492	44e0c549-10c4-4bd0-9e8a-075e2ac63d88	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1492	NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]	20	Current NDC, Legacy NDC, 2 package rows	20240518_d56b330a-4355-4636-9d26-c592f67cea56.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 · 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 ndc (product): 50090-1492
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

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
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	d56b330a-4355-4636-9d26-c592f67cea56	20
606728	NexIUM 20 MG Delayed Release Oral Capsule	PSN	d56b330a-4355-4636-9d26-c592f67cea56	20
606728	esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]	SBD	d56b330a-4355-4636-9d26-c592f67cea56	20
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	d56b330a-4355-4636-9d26-c592f67cea56	20
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	d56b330a-4355-4636-9d26-c592f67cea56	20
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	d56b330a-4355-4636-9d26-c592f67cea56	20
606728	Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Capsule	SY	d56b330a-4355-4636-9d26-c592f67cea56	20
606728	Nexium 20 MG Delayed Release Oral Capsule	SY	d56b330a-4355-4636-9d26-c592f67cea56	20
606728	Nexium 24 HR 20 MG Delayed release Oral Capsule	SY	d56b330a-4355-4636-9d26-c592f67cea56	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1492-0	50090149200	3 BOTTLE in 1 CARTON (50090-1492-0) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2014-12-04	0000-00-00	No	No	Current