Acid Reducer

Product NDC: 59726-056
Requested package NDC: 59726-056-14
11-digit product format: 597260056
Labeler code: 59726
Product ID: 59726-056_03fda90d-5e9e-4340-899b-0e3734510a66
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole magnesium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: P & L Development, LLC
Application: ANDA212088
Marketing category: ANDA
Marketing start: 2020-12-31
Marketing end: 2026-06-30
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
Current FDA listing: Yes

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	59726-056	59726-056-14	D	Discontinued by firm		2026-08-03

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
A212088-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2020-06-25

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.

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	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212088-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-25	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59726-056-14	Acid Reducer	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	4
59726-056-14	Acid Reducer	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	4
59726-056-42	Acid Reducer	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	4
59726-056-42	Acid Reducer	14 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	14	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59726-056	ACID REDUCER (ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [P & L DEVELOPMENT, LLC]	4	Current NDC, Legacy NDC, 4 package rows	20241103_08f09939-10d1-4380-81bb-826856444674.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acid Reducer	ESOMEPRAZOLE MAGNESIUM	Walgreens	4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc6	2026-03-25	Warnings	Exact identifier application applno (ANDA): 212088 application number: ANDA212088
Acid Reducer	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy	001817ea-906e-47f7-8605-41ba5a9abd21	2026-01-21	Warnings	Exact identifier application applno (ANDA): 212088 application number: ANDA212088

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
433733	esomeprazole magnesium 20 MG Delayed Release Oral Tablet	PSN	08f09939-10d1-4380-81bb-826856444674	4
433733	esomeprazole 20 MG Delayed Release Oral Tablet	SCD	08f09939-10d1-4380-81bb-826856444674	4
433733	esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Tablet	SY	08f09939-10d1-4380-81bb-826856444674	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59726-056-14	59726005614	1 BOTTLE in 1 CARTON (59726-056-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2020-12-31	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium Delayed-Release Capsules 20 mg - Actavis	P & L Development, LLC	2024-11-01	HUMAN OTC DRUG LABEL	4