Esomeprazole Magnesium

Product NDC: 53943-039
11-digit product format: 539430039
Labeler code: 53943
Product ID: 53943-039_9dcb83ae-d073-e829-0d40-b939b9c9e113
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: DISCOUNT DRUG MART, 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

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
144fcd6b-2b40-f84b-c559-07a847b27638	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
53943-039-14	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	1
53943-039-14	Esomeprazole Magnesium	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	1
53943-039-42	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	1
53943-039-42	Esomeprazole Magnesium	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-039	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DISCOUNT DRUG MART, INC. ]	1	Current NDC, 4 package rows	20250302_144fcd6b-2b40-f84b-c559-07a847b27638.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 ndc (product): 53943-039
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

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	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	Units	Marketing start	Sample	Exclude flag	Status
53943-039-14	53943003914	1 BOTTLE in 1 CARTON (53943-039-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2025-03-15	No	No	Current
53943-039-42	53943003942	3 BOTTLE in 1 CARTON (53943-039-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2025-03-15	No	No	Current