NEXIUM

Product NDC: 61919-509
11-digit product format: 619190509
Labeler code: 61919
Product ID: 61919-509_852cc99f-e417-0017-e053-2991aa0af97b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: DIRECT RX
Application: NDA021153
Marketing category: NDA
Marketing start: 2014-01-01
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: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-509		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-509	61919-509-30	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-509	61919-509-60	I	Inactivated by FDA	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 2 · 63 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-509-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-509-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-509-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-509-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-509-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-509-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-509-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-509-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-509-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-509-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-509-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-509-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-509-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-509-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-509-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-509-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-509-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-509-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-509-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-509-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-509-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-509-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-509-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-509-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-509-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-509-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-509-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-509-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-509-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-509-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-509-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-509-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-509-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-509-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-509-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-509-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-509-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-509-60	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-509-30	Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-509-60	Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`

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 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
61919-509-30	NEXIUM	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		3
61919-509-60	NEXIUM	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-509-30	EA - Each	61919-509	71e5d6a4-110b-4220-a779-3899f6a90a49	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESOMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	R6DXU4WAY9	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEXIUM GRANULE, DELAYED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-509	NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECT RX]	3	Legacy NDC, 2 package rows	20190330_adaf210b-9a04-42f0-8887-2e1252efd1e2.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): 021153 application number: NDA021153

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
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	adaf210b-9a04-42f0-8887-2e1252efd1e2	3
606731	NexIUM 40 MG Delayed Release Oral Capsule	PSN	adaf210b-9a04-42f0-8887-2e1252efd1e2	3
606731	esomeprazole 40 MG Delayed Release Oral Capsule [Nexium]	SBD	adaf210b-9a04-42f0-8887-2e1252efd1e2	3
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	adaf210b-9a04-42f0-8887-2e1252efd1e2	3
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	adaf210b-9a04-42f0-8887-2e1252efd1e2	3
606731	Nexium 40 MG (as esomeprazole magnesium trihydrate 44.5 MG) Delayed Release Oral Capsule	SY	adaf210b-9a04-42f0-8887-2e1252efd1e2	3
606731	Nexium 40 MG Delayed Release Oral Capsule	SY	adaf210b-9a04-42f0-8887-2e1252efd1e2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-509-30	61919050930	30 in 1 BOTTLE	Historical
61919-509-60	61919050960	60 in 1 BOTTLE	Historical