Omeprazole

Product NDC: 57896-960
11-digit product format: 578960960
Labeler code: 57896
Product ID: 57896-960_9a633bfa-188d-dd42-e053-2995a90ad3aa
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: GERICARE PHARMACEUTICALS
Application: ANDA207740
Marketing category: ANDA
Marketing start: 2018-11-06
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57896-960		D	Discontinued by firm		2026-08-17
excluded package	package	57896-960	57896-960-42	D	Discontinued by firm		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57896-960-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57896-960-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57896-960-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57896-960-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57896-960-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57896-960-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57896-960-42	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57896-960-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57896-960-42	`0efc9e666f02…`	`f202fb6c5f17…`

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
A207740-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL			2018-11-05

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.

Product history page 1 of 2 · 42 observed 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	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-960-42	EA - Each	57896-960	d5d3bcfc-7769-483b-b0e9-874a12559295	1	2019-04-11

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	AMERISOURCEBERGEN DRUG CORPORATION	0521c51b-d113-7e35-f1a6-c4495a2bcfcc	2026-04-17	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Walmart Inc.	5168ccd9-31b4-3a49-85b9-4f202cd99f6b	2026-03-19	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Chain Drug Marketing Association INC	77d4f6c7-87ca-78bb-3310-2304a68f9f9b	2025-01-17	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Dr. Reddys Laboratories Inc	4b3b389d-a151-d851-cb05-64eb49979e5e	2024-12-19	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Walgreens Company	5e2994fc-8f44-f6e4-71fe-44a215aa93a9	2024-11-10	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	Dr. Reddys Laboratories Inc	b377cb0b-14b2-04bb-f276-fd69a257f9ca	2024-11-10	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740
Omeprazole	OMEPRAZOLE	BluePoint Laboratories	a86d52a5-15e2-012d-e053-2a95a90ac912	2023-09-13	Warnings	Exact identifier application applno (ANDA): 207740 application number: ANDA207740

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-960-42	57896096042	3 BOTTLE in 1 CARTON (57896-960-42) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57896-960-14)	3 bottle	2018-11-06	0000-00-00	No	No	Current