Esomeprazole Magnesium

Product NDC: 58602-840
11-digit product format: 586020840
Labeler code: 58602
Product ID: 58602-840_5ddd44f1-1baa-4730-b718-5d1c326ecd49
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA214473
Marketing category: ANDA
Marketing start: 2023-07-12
Substance: ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214473-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2023-07-12

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
2026-02-19 14:30 UTC	2026-02	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214473-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2023-07-12	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Esomeprazole Magnesium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
36H71644EQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
433733	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
034bcbad-f57f-4338-a193-7a5aa9f09aa6	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
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	SPL version
58602-840-05	Esomeprazole Magnesium	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	3
58602-840-05	Esomeprazole Magnesium	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	3
58602-840-61	Esomeprazole Magnesium	2 in 1 CARTON	TABLET, DELAYED RELEASE	2	3
58602-840-61	Esomeprazole Magnesium	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	3
58602-840-62	Esomeprazole Magnesium	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	3
58602-840-62	Esomeprazole Magnesium	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-840	ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [AUROHEALTH LLC]	2	Current NDC, 6 package rows	20240630_034bcbad-f57f-4338-a193-7a5aa9f09aa6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurohealth LLC	034bcbad-f57f-4338-a193-7a5aa9f09aa6	2026-02-12	Warnings	Exact identifier application applno (ANDA): 214473 application number: ANDA214473 ndc (product): 58602-840
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy, Inc.	1867185e-9c34-c8cc-e063-6394a90ab3b1	2024-07-09	Warnings	Exact identifier application applno (ANDA): 214473 application number: ANDA214473
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	WALGREEN CO.	179b23c4-2a6c-f658-e063-6394a90a82b3	2024-07-08	Warnings	Exact identifier application applno (ANDA): 214473 application number: ANDA214473
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Cardinal Health	90df7bbb-c55e-4a01-90b7-c118b65617a9	2024-06-27	Warnings	Exact identifier application applno (ANDA): 214473 application number: ANDA214473

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
433733	esomeprazole magnesium 20 MG Delayed Release Oral Tablet	PSN	034bcbad-f57f-4338-a193-7a5aa9f09aa6	3
433733	esomeprazole 20 MG Delayed Release Oral Tablet	SCD	034bcbad-f57f-4338-a193-7a5aa9f09aa6	3
433733	esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral Tablet	SY	034bcbad-f57f-4338-a193-7a5aa9f09aa6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58602-840-05	58602084005	1 BOTTLE in 1 CARTON (58602-840-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2023-07-12	No	No	Current
58602-840-61	58602084061	2 BOTTLE in 1 CARTON (58602-840-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	2 bottle	2023-07-12	No	No	Current
58602-840-62	58602084062	3 BOTTLE in 1 CARTON (58602-840-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2023-07-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium Delayed-Release Tablets 20 mg *	Aurohealth LLC \| Aurobindo Pharma Limited	2026-02-12	Human OTC Drug Label	3