Esomeprazole

Product NDC: 63304-740
11-digit product format: 633040740
Labeler code: 63304
Product ID: 63304-740_6ac3f3a4-98df-4eb3-9b9e-c85253811b85
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA212866
Marketing category: ANDA
Marketing start: 2019-11-30
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-740		D	Discontinued by firm	2026-08-07
excluded package	package	63304-740	63304-740-14	D	Discontinued by firm	2026-08-07
excluded package	package	63304-740	63304-740-27	D	Discontinued by firm	2026-08-07
excluded package	package	63304-740	63304-740-44	D	Discontinued by firm	2026-08-07

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-740	ESOMEPRAZOLE CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5	Legacy NDC	20200513_86aa9813-351c-4fbe-80f6-4f861f25fe1d.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
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
N3PA6559FT	ESOMEPRAZOLE	119141-88-7	Esomeprazole

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-740-14	63304074014	1 BOTTLE in 1 CARTON (63304-740-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2019-11-30	0000-00-00	No	No	Current
63304-740-27	63304074027	2 BOTTLE in 1 CARTON (63304-740-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2 bottle	2019-11-30	0000-00-00	No	No	Current
63304-740-44	63304074044	3 BOTTLE in 1 CARTON (63304-740-44) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2019-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc. \| Sun Pharmaceutical Industries Limited	2020-05-12	HUMAN OTC DRUG LABEL	5