NEXIUM

Product NDC: 0186-4025
Requested package NDC: 0186-4025-02
11-digit product format: 001864025
Labeler code: 0186
Product ID: 0186-4025_26f66e74-b652-4b1d-bfff-62a3cc87d590
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole magnesium
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA021957
Marketing category: NDA
Marketing start: 2012-06-01
Substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength: 2.5 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0186-4025	0186-4025-02	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021957-001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20
N021957-002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20
N021957-003	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15
N021957-004	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021957-001	AB
N021957-002	AB
N021957-003	AB
N021957-004	AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021957-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021957-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021957-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021957-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021957-002	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 56 observed states.

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	N021957-001	6428810	2019-11-03	U-1207	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810	2019-11-03	U-773	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810	2019-11-03	U-729	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810	2019-11-03	U-1207	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810	2019-11-03	U-729	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810	2019-11-03	U-773	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-003	6428810	2019-11-03	U-1207	Drug product	2012-01-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-004	6428810	2019-11-03	U-1207	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810	2019-11-03	U-1207	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810	2019-11-03	U-773	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810	2019-11-03	U-729	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810	2019-11-03	U-1207	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810	2019-11-03	U-729	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810	2019-11-03	U-773	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-003	6428810	2019-11-03	U-1207	Drug product	2012-01-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-004	6428810	2019-11-03	U-1207	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810	2019-11-03	U-1207	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810	2019-11-03	U-773	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810	2019-11-03	U-729	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810	2019-11-03	U-1207	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810	2019-11-03	U-729	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810	2019-11-03	U-773	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`

Additional Listing Data#

Finished product: Yes
Brand name base: NEXIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE	2.5 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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
606726	Internal RxNorm lookup
606728	Internal RxNorm lookup
606730	Internal RxNorm lookup
606731	Internal RxNorm lookup
692576	Internal RxNorm lookup
692578	Internal RxNorm lookup
861568	Internal RxNorm lookup
861570	Internal RxNorm lookup
861576	Internal RxNorm lookup
861583	Internal RxNorm lookup
1297658	Internal RxNorm lookup
1297660	Internal RxNorm lookup
1297761	Internal RxNorm lookup
1297763	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
f4853677-1622-4037-688b-fdf533a11d96	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0186-4025-01	NEXIUM	30 in 1 CARTON	GRANULE, DELAYED RELEASE	30		74
0186-4025-02	NEXIUM	5 in 1 CARTON	GRANULE, DELAYED RELEASE	5		74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0186-4025-01	EA - Each	0186-4025	785bd98f-d740-42a5-b6cf-1bd9a449771f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESOMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	R6DXU4WAY9	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0186-4025	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	72	Current NDC, Legacy NDC, 2 package rows	20240628_f4853677-1622-4037-688b-fdf533a11d96.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	ESOMEPRAZOLE MAGNESIUM	AstraZeneca Pharmaceuticals LP	f4853677-1622-4037-688b-fdf533a11d96	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021957 application number: NDA021957 ndc (package): 0186-4025-02 ndc (product): 0186-4025 ndc11 (package): 00186402502

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
861568	esomeprazole 10 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
1297658	esomeprazole 2.5 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
692576	esomeprazole 20 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
692578	esomeprazole 40 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
1297761	esomeprazole 5 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
861570	NexIUM 10 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
1297660	NexIUM 2.5 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
606728	NexIUM 20 MG Delayed Release Oral Capsule	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
861576	NexIUM 20 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
606731	NexIUM 40 MG Delayed Release Oral Capsule	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
861583	NexIUM 40 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
1297763	NexIUM 5 MG Granules for Delayed Release Oral Suspension	PSN	f4853677-1622-4037-688b-fdf533a11d96	74
861570	esomeprazole 10 MG Granules for Oral Suspension [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
1297660	esomeprazole 2.5 MG Granules for Oral Suspension [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
606728	esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
861576	esomeprazole 20 MG Granules for Oral Suspension [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
606731	esomeprazole 40 MG Delayed Release Oral Capsule [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
861583	esomeprazole 40 MG Granules for Oral Suspension [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
1297763	esomeprazole 5 MG Granules for Oral Suspension [Nexium]	SBD	f4853677-1622-4037-688b-fdf533a11d96	74
861568	esomeprazole 10 MG Granules for Oral Suspension	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
1297658	esomeprazole 2.5 MG Granules for Oral Suspension	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
692576	esomeprazole 20 MG Granules for Oral Suspension	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
692578	esomeprazole 40 MG Granules for Oral Suspension	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
1297761	esomeprazole 5 MG Granules for Oral Suspension	SCD	f4853677-1622-4037-688b-fdf533a11d96	74
1297658	esomeprazole (as esomeprazole magnesium) 2.5 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
692576	esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
861568	esomeprazole 10 MG (equivalent to esomeprazole magnesium 11.1 MG) Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
861568	esomeprazole 10 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
692576	esomeprazole 20 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
692578	esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
692578	esomeprazole 40 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
1297761	esomeprazole 5 MG (equivalent to esomeprazole magnesium 5.6 MG) Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
861570	Nexium 10 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
1297660	Nexium 2.5 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606728	Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606728	Nexium 20 MG Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
861576	Nexium 20 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606728	Nexium 24 HR 20 MG Delayed release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606731	Nexium 40 MG (as esomeprazole magnesium trihydrate 44.5 MG) Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
606731	Nexium 40 MG Delayed Release Oral Capsule	SY	f4853677-1622-4037-688b-fdf533a11d96	74
861583	Nexium 40 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74
1297763	Nexium 5 MG Granules for Delayed Release Oral Suspension	SY	f4853677-1622-4037-688b-fdf533a11d96	74

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0186-4025-02	00186402502	5 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4025-02)	2012-09-05	0000-00-00	Yes	No	Current