Esomeprazole Magnesium

Product NDC: 0615-8396
11-digit product format: 006158396
Labeler code: 0615
Product ID: 0615-8396_0300c30b-ed64-4d94-8ccc-c77ea3ad4419
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA205606
Marketing category: ANDA
Marketing start: 2016-04-21
Marketing end: 2026-05-31
Substance: ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength: 40 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-8396		D	Discontinued by firm		2026-08-17
excluded package	package	0615-8396	0615-8396-39	D	Discontinued by firm		2026-08-17

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
A205606-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-04-21
A205606-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205606-001	AB
A205606-002	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 · 84 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	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205606-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205606-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2016-04-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A205606-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205606-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205606-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205606-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205606-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205606-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205606-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205606-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0615-8396-39	Esomeprazole Magnesium	30 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	30		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8396	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	14	Current NDC, Legacy NDC, 1 package rows	20240918_213ccff1-4982-426b-a4f8-ecb2f2ee6dc6.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	71a4fa85-032b-4f50-a2ee-fd9642ae8b15	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	6ad71713-39da-460b-81fc-e5fba103b215	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NCS HealthCare of KY, LLC dba Vangard Labs	28fbfa02-6c7b-4eb1-af24-86825e652326	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	PD-Rx Pharmaceuticals, Inc.	ac12cd05-10cf-4694-a9e8-e5f04fe162a7	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	7038a0bc-99b2-4a6e-9b9a-0646ec187706	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	f4ae091d-9b74-4a0e-ac68-057effd91e17	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium DR	ESOMEPRAZOLE MAGNESIUM	Advanced Rx Pharmacy of Tennessee, LLC	b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	009794ae-8199-4176-9dc6-4c5e752d845c	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205606 application number: ANDA205606

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8396-39	00615839639	30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8396-39)	2021-06-22	2026-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-16	HUMAN PRESCRIPTION DRUG LABEL	15