Esomeprazole Magnesium

Product NDC: 43598-327
Requested package NDC: 43598-327-94
11-digit product format: 435980327
Labeler code: 43598
Product ID: 43598-327_80664ea4-4cd2-43cd-2055-2bd69dec3768
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: ANDA207198
Marketing category: ANDA
Marketing start: 2025-03-01
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: 2026-12-31
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
unfinished package	package	43598-327	43598-327-94	UNFINISHED	Active or certified unfinished drug listing		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 · 8 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`

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

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
A207198-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2024-04-30

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
2026-08-18 06:07:40	2026-07	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207198-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2024-04-30	`a50c72e98297…`

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	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
606726	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
fca35363-7d27-b8b3-14c0-56f603652053	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
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
43598-327-27	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	8
43598-327-27	Esomeprazole Magnesium	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	8
43598-327-33	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	8
43598-327-33	Esomeprazole Magnesium	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	8
43598-327-52	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	8
43598-327-52	Esomeprazole Magnesium	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-327	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]	8	Current NDC, 6 package rows	20250302_fca35363-7d27-b8b3-14c0-56f603652053.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	Dr. Reddy's Laboratories Inc	8bceb7b3-d0a4-6e53-6957-8104a6b927e4	2025-11-04	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	KROGER COMPANY	d001e9c2-1c70-7ff6-ad72-c431a46d1771	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	WALGREENS COMPANY	993f86d0-c18b-a843-6adf-e8a967da3745	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	1edcb0be-7af2-c08c-dab2-0be03364a140	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	H E B	a5a6f614-2920-d74c-1ddc-9a07a0ec6e05	2025-10-28	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	DISCOUNT DRUG MART, INC.	144fcd6b-2b40-f84b-c559-07a847b27638	2024-11-30	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	fab0b1fa-cf56-d97c-f026-1754cf5b792c	2024-07-08	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc	fca35363-7d27-b8b3-14c0-56f603652053	2024-06-24	Warnings	Exact identifier application applno (ANDA): 207198 application number: ANDA207198 ndc (product): 43598-327

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
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	fca35363-7d27-b8b3-14c0-56f603652053	8
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	fca35363-7d27-b8b3-14c0-56f603652053	8
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	fca35363-7d27-b8b3-14c0-56f603652053	8
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	fca35363-7d27-b8b3-14c0-56f603652053	8
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	1edcb0be-7af2-c08c-dab2-0be03364a140	3
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	a5a6f614-2920-d74c-1ddc-9a07a0ec6e05	3
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	1edcb0be-7af2-c08c-dab2-0be03364a140	3
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	a5a6f614-2920-d74c-1ddc-9a07a0ec6e05	3
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	1edcb0be-7af2-c08c-dab2-0be03364a140	3
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	a5a6f614-2920-d74c-1ddc-9a07a0ec6e05	3
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	a5a6f614-2920-d74c-1ddc-9a07a0ec6e05	3
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	1edcb0be-7af2-c08c-dab2-0be03364a140	3
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	993f86d0-c18b-a843-6adf-e8a967da3745	2
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	d001e9c2-1c70-7ff6-ad72-c431a46d1771	2
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	993f86d0-c18b-a843-6adf-e8a967da3745	2
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	d001e9c2-1c70-7ff6-ad72-c431a46d1771	2
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	993f86d0-c18b-a843-6adf-e8a967da3745	2
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	d001e9c2-1c70-7ff6-ad72-c431a46d1771	2
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	993f86d0-c18b-a843-6adf-e8a967da3745	2
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	d001e9c2-1c70-7ff6-ad72-c431a46d1771	2
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	144fcd6b-2b40-f84b-c559-07a847b27638	1
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	144fcd6b-2b40-f84b-c559-07a847b27638	1
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	144fcd6b-2b40-f84b-c559-07a847b27638	1
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	144fcd6b-2b40-f84b-c559-07a847b27638	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
43598-327-94	43598032794	4000 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-327-94)	01-DEC-24	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	CHAIN DRUG MARKETING ASSOCIATION, INC.	2025-10-28	HUMAN OTC DRUG LABEL	3
Drug Facts	H E B	2025-10-28	HUMAN OTC DRUG LABEL	3
Drug Facts	LEADER/ Cardinal Health 110, Inc.	2025-10-28	HUMAN OTC DRUG LABEL	2
Drug Facts	WALGREENS COMPANY	2025-10-28	HUMAN OTC DRUG LABEL	2
Drug Facts	KROGER COMPANY	2025-10-28	HUMAN OTC DRUG LABEL	2
Drug Facts	DISCOUNT DRUG MART, INC.	2024-11-30	HUMAN OTC DRUG LABEL	1
Drug Facts	Dr. Reddy's Laboratories Inc \| Dr. Reddy's Laboratories Limited - FTO 3 \| Reed Lane Inc	2024-06-24	HUMAN OTC DRUG LABEL	8