Esomeprazole

Product NDC: 57483-900
11-digit product format: 574830900
Labeler code: 57483
Product ID: 57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592b
Type: HUMAN OTC DRUG
Nonproprietary name: esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: INNOVUS PHARMACEUTICALS, INC.
Application: ANDA212866
Marketing category: ANDA
Marketing start: 2020-08-14
Substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 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
A212866-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2020-05-04

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	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212866-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-05-04	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE	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
b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	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
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	Strength	SPL version
57483-900-42	Esomeprazole	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3		3
57483-900-42	Esomeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57483-900	ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [INNOVUS PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20241109_b3d10f0b-52af-408c-9b3d-f8f25f7c42bd.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	Ohm Laboratories Inc.	e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4	2026-06-06	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	YYBA CORP	0912d311-e26c-479d-9f13-ef0ac403e9b8	2025-11-19	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	CVS	b68035d0-195a-41e8-9928-8b1bd57917c0	2025-09-15	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	INNOVUS PHARMACEUTICALS, INC.	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	2024-10-30	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866 ndc (product): 57483-900
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	LITTLE PHARMA, INC.	e45621ea-cc15-4a8e-98d2-d10ab424a45e	2024-06-17	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	VALU MERCHANDISERS COMPANY	ab83bbdd-2c8e-46bd-b39e-69199e004be4	2023-11-03	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE	Safeway, Inc.	7c497204-29ce-45e0-84d4-91b981c9b7aa	2023-08-25	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
Esomeprazole	ESOMEPRAZOLE MAGNESIUM	HARRIS TEETER	ea9ef7b0-7397-470f-b852-397e8b0e66e4	2021-04-30	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866
esomeprazole	ESOMEPRAZOLE	THE KROGER COMPANY	7fa75bbe-5b9f-49ca-84de-f80e5a858de4	2020-10-28	Warnings	Exact identifier application applno (ANDA): 212866 application number: ANDA212866

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	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	3
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	3
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	3
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	b3d10f0b-52af-408c-9b3d-f8f25f7c42bd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57483-900-42	57483090042	3 BOTTLE in 1 CARTON (57483-900-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2020-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	INNOVUS PHARMACEUTICALS, INC. \| Ohm Laboratories Inc.	2024-10-30	HUMAN OTC DRUG LABEL	3