Esomeprazole Magnesium

Product NDC: 43598-510
11-digit product format: 435980510
Labeler code: 43598
Product ID: 43598-510_bc23d230-ec98-ff25-5296-39e31fe9b775
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: ANDA078279
Marketing category: ANDA
Marketing start: 2015-12-10
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 40 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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
A078279-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-09-25
A078279-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078279-001	AB
A078279-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078279-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078279-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-09-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078279-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078279-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078279-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078279-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078279-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078279-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078279-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078279-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078279-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078279-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078279-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078279-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078279-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078279-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078279-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078279-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078279-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078279-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078279-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078279-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078279-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078279-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078279-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078279-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078279-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078279-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078279-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078279-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Esomeprazole Magnesium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R6DXU4WAY9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
606726	Internal RxNorm lookup
606730	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15023261-51c8-2388-3439-48dace49ec02	Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
43598-510-10	Esomeprazole Magnesium	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	12
43598-510-30	Esomeprazole Magnesium	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	12
43598-510-90	Esomeprazole Magnesium	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-510-10	EA - Each	43598-510	8b4d2821-b37a-4d63-8b58-b4e981f5985c	1	2016-06-14
43598-510-30	EA - Each	43598-510	4656b450-5e43-4989-8c50-2d586bb494e9	1	2016-01-13
43598-510-90	EA - Each	43598-510	5029951e-95dd-407b-991c-d97d72f6f539	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-510	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]	12	Current NDC, Legacy NDC, 3 package rows	20230906_15023261-51c8-2388-3439-48dace49ec02.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	a9d05a38-08db-4710-b6f3-20c92ce885d5	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	AvPAK	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals, Inc.	463c9b3b-dd6b-7ee7-e063-6394a90afb43	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	PD-Rx Pharmaceuticals, Inc.	fdea1f5f-b717-4d49-8d70-0b373c959bf0	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	2879c79f-bf2a-0bc9-e063-6394a90a98ae	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Major Pharmaceuticals	ba65c73d-fc7d-491e-aaaa-cf45a7783395	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Medsource Pharmaceuticals	1278cf6f-cc7a-462b-e063-6394a90a34e5	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	71956762-d2f7-4763-9afe-1ca8f32a3cbb	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	99fceec8-59a2-485f-a7f3-7c5afd98401d	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	15023261-51c8-2388-3439-48dace49ec02	2023-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279 ndc (product): 43598-510
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	NorthStar Rx LLC	380da8db-bfa3-8c0c-f8f3-573675fed981	2023-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	e5540d90-0b6e-4519-9272-c6e96730967b	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078279 application number: ANDA078279

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
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	fdea1f5f-b717-4d49-8d70-0b373c959bf0	14
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	fdea1f5f-b717-4d49-8d70-0b373c959bf0	14
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	fdea1f5f-b717-4d49-8d70-0b373c959bf0	14
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	15023261-51c8-2388-3439-48dace49ec02	12
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	15023261-51c8-2388-3439-48dace49ec02	12
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	15023261-51c8-2388-3439-48dace49ec02	12
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	15023261-51c8-2388-3439-48dace49ec02	12
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	15023261-51c8-2388-3439-48dace49ec02	12
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	15023261-51c8-2388-3439-48dace49ec02	12
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	15023261-51c8-2388-3439-48dace49ec02	12
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	ba65c73d-fc7d-491e-aaaa-cf45a7783395	6
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	ba65c73d-fc7d-491e-aaaa-cf45a7783395	6
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	ba65c73d-fc7d-491e-aaaa-cf45a7783395	6
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	3
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	3
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	9224142a-6e14-4ca3-9e72-506ff9fbd0e1	3
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	4db9f4b8-b6df-f6e9-e063-6294a90a9f60	2
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	f2f699d8-c770-c874-e053-2995a90ac6d0	1
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	f2f699d8-c770-c874-e053-2995a90ac6d0	1
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	f2f699d8-c770-c874-e053-2995a90ac6d0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-510-10	43598051010	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-10)	2016-04-28	0000-00-00	No	No	Current
43598-510-30	43598051030	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-30)	2015-12-10	0000-00-00	No	No	Current
43598-510-90	43598051090	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43598-510-90)	2016-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	AvPAK	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	2
Esomeprazole Magnesium	PD-Rx Pharmaceuticals, Inc.	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	14
Esomeprazole Magnesium	Major Pharmaceuticals	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	6
Esomeprazole Magnesium	REMEDYREPACK INC.	2024-03-11	HUMAN PRESCRIPTION DRUG LABEL	5
Esomeprazole Magnesium	Dr. Reddy's Laboratories Inc \| Dr. Reddy's Laboratories Limited-FTO 3	2023-07-25	HUMAN PRESCRIPTION DRUG LABEL	12
Esomeprazole Magnesium	NuCare Pharmaceuticals,Inc.	2023-01-23	HUMAN PRESCRIPTION DRUG LABEL	1
Esomeprazole Magnesium	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	3