ESOMEPRAZOLE MAGNESIUM

Product NDC: 61919-834
11-digit product format: 619190834
Labeler code: 61919
Product ID: 61919-834_267916e4-c6ac-43b5-9d81-be20ff1b15d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESOMEPRAZOLE MAGNESIUM
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: DirectRX
Application: ANDA078279
Marketing category: ANDA
Marketing start: 2015-01-01
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: 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	61919-834		I	Inactivated by FDA		2026-08-11
excluded package	package	61919-834	61919-834-30	I	Inactivated by FDA		2026-08-11

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 · 44 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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	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	61919-834-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-834-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-834-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
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…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-834-30	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
A078279-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-09-25
A078279-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078279-001	AB
A078279-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`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	A078279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078279-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078279-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078279-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078279-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078279-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078279-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078279-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078279-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078279-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078279-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078279-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078279-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078279-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078279-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078279-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078279-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078279-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	8	20171212
094c6751-235c-4d12-acee-2baf94f676f4	Product name	1	20151116
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-834-30	2020-01-31	C162847	48780-1	9d75b9d0-2287-f424-e053-dadaa90a57ce	ESOMEPRAZOLE MAGNESIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-834-30	ESOMEPRAZOLE MAGNESIUMD/R	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-834-30	EA - Each	61919-834	cea7d494-f590-4bce-9ea3-b9838c6e3f42	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Esomeprazole Magnesium	ACTIVE INGREDIENT	R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Ammonia	INACTIVE INGREDIENT	5138Q19F1X	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Butyl Alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Fd&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Methacrylic Acid	INACTIVE INGREDIENT	1CS02G8656	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Shellac	INACTIVE INGREDIENT	46N107B71O	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1
Triethyl Citrate	INACTIVE INGREDIENT	8Z96QXD6UM	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-834	ESOMEPRAZOLE MAGNESIUM D/R (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [DIRECTRX]	1	Legacy NDC, 1 package rows	20151021_d3679d70-faa3-41e0-93a5-3f4cb7b6a1ad.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	a9d05a38-08db-4710-b6f3-20c92ce885d5	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	AvPAK	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals, Inc.	463c9b3b-dd6b-7ee7-e063-6394a90afb43	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	PD-Rx Pharmaceuticals, Inc.	fdea1f5f-b717-4d49-8d70-0b373c959bf0	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	2879c79f-bf2a-0bc9-e063-6394a90a98ae	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Major Pharmaceuticals	ba65c73d-fc7d-491e-aaaa-cf45a7783395	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Medsource Pharmaceuticals	1278cf6f-cc7a-462b-e063-6394a90a34e5	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	71956762-d2f7-4763-9afe-1ca8f32a3cbb	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	99fceec8-59a2-485f-a7f3-7c5afd98401d	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	15023261-51c8-2388-3439-48dace49ec02	2023-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NorthStar Rx LLC	380da8db-bfa3-8c0c-f8f3-573675fed981	2023-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	e5540d90-0b6e-4519-9272-c6e96730967b	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279

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	d3679d70-faa3-41e0-93a5-3f4cb7b6a1ad	1
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	d3679d70-faa3-41e0-93a5-3f4cb7b6a1ad	1
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	d3679d70-faa3-41e0-93a5-3f4cb7b6a1ad	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-834-30	61919083430	30 in 1 BOTTLE	Historical