Esomeprazole Magnesium

Product NDC: 55910-016
Requested package NDC: 55910-016-03
11-digit product format: 559100016
Labeler code: 55910
Product ID: 55910-016_dc8b4dc8-7621-43dd-a61d-5f768d5bcd38
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dolgencorp, LLC
Application: ANDA209339
Marketing category: ANDA
Marketing start: 2017-10-16
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55910-016	55910-016-03	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

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

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209339-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2017-10-16

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209339-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-10-16	`cb3db0bc1861…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	d0733d37-cc9c-41ba-9c5f-a0f8bf5a2364	2026-05-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	YYBA CORP	4a7f3a55-862f-111f-e063-6294a90a6a44	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	LEADER/ CARDINAL HEALTH 110, INC.	aef20ccb-1eb7-4c79-af8e-81220eb73752	2025-11-18	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	212cca98-786f-4677-b687-fff81a1dd59f	2025-11-14	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Amerisource Bergen	3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46	2025-08-30	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	b594f052-b6be-4d3b-9316-29cab050344a	2025-05-20	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	LEADER/ CARDINAL HEALTH 110, INC.	c98b4332-ce47-422e-be54-f3eee0762354	2025-04-24	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	5647bfb0-6af0-4580-b202-0f1fc9c41265	2025-03-13	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Publix	c45fd180-9d81-41e0-b7f8-025b8f29763a	2025-02-21	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy, Inc.	d226cda0-5cdb-4e2d-a865-530a8f09a095	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	INNOVUS PHARMACEUTICALS, INC.	a32039b7-8475-4ec5-abaf-07f9aee3954b	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Family Dollar Stores, LLC	f86ba9b5-736e-b279-e053-6394a90acf7c	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Ahold U.S.A., Inc,	7bb719a0-9836-6752-e053-2a91aa0a2f48	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Better Living Brands LLC	ee6e3f66-4eb9-4094-afcc-aaa020942b39	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Best Choice	56120925-28e3-4e6c-b54d-490d7460984f	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	WALGREEN CO.	f9e10472-c6a3-402c-b6a2-f8700ad73e9f	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	f9a5431a-ea03-441f-9064-6e7f30b61674	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Wal-Mart Stores, Inc.	c14f096d-ea1f-4539-8ad0-bb9907745cfc	2024-04-27	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Amerisource Bergen	c94eb997-07d4-4d2e-b213-9a0d51db41c0	2024-03-29	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Retail Business Services, LLC.	ce376d91-0ea8-4922-9f7f-707420cb1d96	2021-03-12	Warnings	Exact identifier application applno (ANDA): 209339 application number: ANDA209339

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
36H71644EQ	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	217087-10-0	ESOMEPRAZOLE MAGNESIUM DIHYDRATE
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	Esomeprazole Magnesium

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-016-03	55910001603	2 BOTTLE in 1 CARTON (55910-016-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2 bottle	2017-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg*	Dolgencorp, LLC \| Aurohealth LLC \| Aurobindo Pharma Limited	2021-03-11	Human OTC Drug Label	5