NEXIUM

Product NDC: 55154-9616
11-digit product format: 551549616
Labeler code: 55154
Product ID: 55154-9616_2d4fa32e-a74d-4507-849a-c16da6329361
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Cardinal Health
Application: NDA021153
Marketing category: NDA
Marketing start: 2001-03-19
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 40 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	55154-9616		D	Discontinued by firm		2026-08-03
excluded package	package	55154-9616	55154-9616-7	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 · 25 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-9616-7	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-9616-7	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-9616-7	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-9616-7	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-9616-7	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-9616-7	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-9616-7	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-9616-7	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-9616-7	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-9616-7	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-9616-7	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-9616-7	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021153-001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20
N021153-002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021153-001	AB
N021153-002	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 3 · 82 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	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N021153-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021153-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021153-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021153-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021153-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021153-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021153-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021153-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021153-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021153-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021153-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021153-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021153-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021153-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021153-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021153-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-729	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-770	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-469	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6166213*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6191148*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-770	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-729	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-469	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-729	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-770	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-469	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6166213*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6191148*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-770	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-729	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-469	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-729	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-770	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-469	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`b00525d2431f…`

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 [CARDINAL HEALTH]	2
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	2

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): 021153 application number: NDA021153