Esomeprazole

Product NDC: 69618-056
11-digit product format: 696180056
Labeler code: 69618
Product ID: 69618-056_c928000b-a4cf-6fb0-e053-2995a90a7eef
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole
Dosage form: CAPSULE
Route: ORAL
Labeler: Reliable 1 Laboratories
Application: ANDA207673
Marketing category: ANDA
Marketing start: 2018-11-01
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE MAGNESIUM
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69618-056		I	Inactivated by FDA		2026-08-11
excluded package	package	69618-056	69618-056-42	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 · 30 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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`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	69618-056-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69618-056-42	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69618-056-42	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69618-056-42	`1332a3947898…`	`d4bfe170f9cd…`

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
A207673-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2018-05-15

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	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207673-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-05-15	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69618-056-42	2023-01-30	C162847	48780-1	c7ccaba7-127b-fd44-e053-dadaa90aa01b	Reliable-1 Esomeprazole Magnesium DR Capsules
69618-056-42	2021-08-09	C162847	48780-1	c7ccaba7-127b-fd44-e053-dadaa90aa01b	Reliable-1 Esomeprazole Magnesium DR Capsules
69618-056-42	2021-07-23	C162847	48780-1	c7ccaba7-127b-fd44-e053-dadaa90aa01b	Reliable-1 Esomeprazole Magnesium DR Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-056-14	Esomeprazole	14 in 1 BOTTLE, PLASTIC	CAPSULE	14		2
69618-056-42	Esomeprazole	3 in 1 CARTON	CAPSULE	3		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-056-14	EA - Each	69618-056	6ff2d3b4-243d-41a7-b1d5-7391cc69cfea	1	2019-01-24
69618-056-42	EA - Each	69618-056	fae021f5-ade7-42ec-836a-1a04495216e9	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-056	ESOMEPRAZOLE CAPSULE [RELIABLE 1 LABORATORIES]	2	Legacy NDC, 2 package rows	20210810_7a7b80f1-fd8a-a78f-e053-2991aa0a7098.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Walgreens Company	f97f8604-9f00-6ed5-ae25-fedc8cf36a5d	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CHAIN DRUG MARKETING ASSOCIATION INC	f95053ab-d6c5-ee92-58d1-6f203873f79c	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	HEB	e3747f1e-01e7-f3cf-499e-c7c3f6d06a30	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc.	945beb4b-8a31-d904-8881-1cf839604347	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	The Kroger Co.	b4cdf878-61d3-01bd-48c9-4d6f4fbc71df	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Discount Drug Mart, Inc	0d6e66c5-ca6d-5cda-72d7-9350dbd1eba0	2024-12-16	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	cb8297ad-ce1b-aa31-2488-5a38b2dbc774	2022-09-30	Warnings	Exact identifier application applno (ANDA): 207673 application number: ANDA207673

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	ESOMEPRAZOLE MAGNESIUM
N3PA6559FT	ESOMEPRAZOLE	119141-88-7	Esomeprazole

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	7a7b80f1-fd8a-a78f-e053-2991aa0a7098	2
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	7a7b80f1-fd8a-a78f-e053-2991aa0a7098	2
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	7a7b80f1-fd8a-a78f-e053-2991aa0a7098	2
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	7a7b80f1-fd8a-a78f-e053-2991aa0a7098	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69618-056-14	69618005614	14 in 1 BOTTLE, PLASTIC					Historical
69618-056-42	69618005642	3 BOTTLE, PLASTIC in 1 CARTON (69618-056-42) > 14 CAPSULE in 1 BOTTLE, PLASTIC (69618-056-14)	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Reliable-1 Esomeprazole Magnesium DR Capsules	Reliable 1 Laboratories	2021-08-09	HUMAN OTC DRUG LABEL	2