ESOMEPRAZOLE MAGNESIUM

Product NDC: 13668-154
11-digit product format: 136680154
Labeler code: 13668
Product ID: 13668-154_89387fd0-ce27-4f1a-a331-53c23ac58a23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESOMEPRAZOLE MAGNESIUM
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA203636
Marketing category: ANDA
Marketing start: 2015-10-19
Marketing end: 0000-00-00
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: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-154		D	Discontinued by firm	2026-10-05
excluded package	package	13668-154	13668-154-05	D	Discontinued by firm	2026-10-05
excluded package	package	13668-154	13668-154-10	D	Discontinued by firm	2026-10-05
excluded package	package	13668-154	13668-154-30	D	Discontinued by firm	2026-10-05
excluded package	package	13668-154	13668-154-90	D	Discontinued by firm	2026-10-05

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-154-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-154-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-154-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-154-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-154-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-154-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-154-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-154-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-154-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-154-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-154-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-154-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-154-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-154-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-154-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-154-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-154-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-154-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-154-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-154-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-154-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-154-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-154-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-154-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-154-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-154-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-154-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-154-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-154-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-154-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-154-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-154-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-154-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-154-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-154-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-154-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-154-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-154-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-154-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-154-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-154-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-154-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-154-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-154-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-154-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-154-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-154-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-154-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203636-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2015-10-19
A203636-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL			2015-10-19

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2015-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203636-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203636-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-10-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203636-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203636-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203636-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203636-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203636-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203636-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203636-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203636-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203636-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203636-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203636-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203636-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203636-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203636-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203636-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203636-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203636-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203636-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203636-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203636-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203636-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203636-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203636-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203636-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203636-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203636-002	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203636-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203636-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203636-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203636-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203636-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203636-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203636-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203636-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203636-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203636-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203636-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203636-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203636-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203636-002	AB	1	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-154-10	EA - Each	13668-154	f425864b-d001-493b-a003-5aab151ee684	1	2015-11-12
13668-154-30	EA - Each	13668-154	98b9c3c3-46c2-41e9-94f8-f71ed4e83214	1	2015-11-12
13668-154-90	EA - Each	13668-154	e14926ed-5488-4550-aaa7-6c29c5f07d39	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESOMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	1

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	e6db8cb7-6c39-4692-a1ff-50f056946df9	9
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	e6db8cb7-6c39-4692-a1ff-50f056946df9	9
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	e6db8cb7-6c39-4692-a1ff-50f056946df9	9
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	e6db8cb7-6c39-4692-a1ff-50f056946df9	9
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	e6db8cb7-6c39-4692-a1ff-50f056946df9	9
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	e6db8cb7-6c39-4692-a1ff-50f056946df9	9
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	e6db8cb7-6c39-4692-a1ff-50f056946df9	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-154-05	13668015405	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-05)	2015-10-19	0000-00-00	No	No	Current
13668-154-10	13668015410	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-10)	2015-10-19	0000-00-00	No	No	Current
13668-154-30	13668015430	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-30)	2015-10-19	0000-00-00	No	No	Current
13668-154-74	13668015474	100 CAPSULE, DELAYED RELEASE in 1 CARTON (13668-154-74)	2015-10-19	0000-00-00	No	No	Current
13668-154-90	13668015490	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-154-90)	2015-10-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESOMEPRAZOLE MAGNESIUM	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	13
ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	2022-09-30	HUMAN PRESCRIPTION DRUG LABEL	1020
ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	2021-06-17	HUMAN PRESCRIPTION DRUG LABEL	9
ESOMEPRAZOLE MAGNESIUM	Quality Care Products, LLC	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	2
ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	2019-11-25	HUMAN PRESCRIPTION DRUG LABEL	2