Esomeprazole Magnesium

Product NDC: 68788-8160
Requested package NDC: 68788-8160-6
11-digit product format: 687888160
Labeler code: 68788
Product ID: 68788-8160_d47c8c14-d4a1-4351-936a-9a0af3bd3740
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA211977
Marketing category: ANDA
Marketing start: 2022-04-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-8160	68788-8160-6	D	Discontinued by firm		2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-8160	68788-8160-6	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211977-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-06-02
A211977-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211977-001	AB
A211977-002	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 2 · 76 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
2026-08-18 06:07:40	2026-07	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211977-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211977-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211977-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211977-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211977-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211977-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211977-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211977-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211977-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211977-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211977-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211977-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211977-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211977-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211977-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211977-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211977-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8160-1	EA - Each	68788-8160	e1898f78-762c-458a-a00b-01b611316a45	1	2022-05-04
68788-8160-2	EA - Each	68788-8160	ebac3a1e-62f8-400f-b1bb-a41d5893222c	1	2022-05-04
68788-8160-3	EA - Each	68788-8160	c3d5cd34-f9cc-4399-9a14-a7a6bba7a063	1	2022-05-04
68788-8160-6	EA - Each	68788-8160	e9f4e055-893b-4803-843a-281a68dddc19	1	2022-05-04
68788-8160-9	EA - Each	68788-8160	93560d3d-5569-4a5d-bce6-7cbf5c9058b3	1	2022-05-04

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	American Health Packaging	9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	REMEDYREPACK INC.	ab3d31c8-cab1-4c44-bacd-5e5c67dd1384	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	27e7f7f0-7403-4425-8baa-d12ae9321364	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	00aa81c2-73c7-4bf8-94e9-f644381b631f	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Asclemed USA, Inc.	2690dbe7-e559-4de8-9582-79b627af1964	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole DR	ESOMEPRAZOLE DR	Direct_Rx	e8937778-8baf-05f5-e053-2995a90a3a98	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Direct Rx	d5f56bd4-3a59-6857-e053-2995a90a6e00	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium DR	ESOMEPRAZOLE MAGNESIUM	Advanced Rx Pharmacy of Tennessee, LLC	fab87a2d-79c8-6045-e053-6394a90a2368	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	42b8d3f5-d919-48dd-92e4-ed49488dd664	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	7778bf7c-52f7-44b3-ac2c-e5a25f6967b7	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	61cc0020-aab8-42a3-b0a6-93062f382c87	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1e92676a-6c59-796d-e063-6294a90aaab4	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1d8bd104-66d4-8c19-e063-6394a90a3cb6	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Pharmaceuticals, Inc.	c18067ba-26ba-40b4-a328-3011710be216	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	ESOMEPRAZOLE MAGNESIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8160-6	68788816006	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8160-6)	2022-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	Preferred Pharmaceuticals, Inc.	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	5