family wellness omeprazole

Product NDC: 55319-191
11-digit product format: 553190191
Labeler code: 55319
Product ID: 55319-191_56e6ee5e-3598-4c3d-838f-4cf07272e739
Type: HUMAN OTC DRUG
Nonproprietary name: omeprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Family Dollar Services Inc
Application: NDA209400
Marketing category: NDA
Marketing start: 2019-03-26
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	55319-191		D	Discontinued by firm		2026-08-03
excluded package	package	55319-191	55319-191-74	D	Discontinued by firm		2026-08-03

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 · 24 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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`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	55319-191-74	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55319-191-74	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55319-191-74	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55319-191-74	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N209400-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		RLD, RS	2017-07-05

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209400-001	10076494	2036-12-08		Drug product	2018-09-18
N209400-001	10835488	2036-12-08		Drug product	2020-11-23

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 77 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`87673890dc5c…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone omeprazole	OMEPRAZOLE	American Sales Company	5b88717a-e90c-4e74-ae2a-29270e14a3cc	2026-07-08	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	Rite Aid Corporation	6919399e-f112-4274-b4de-df0b4c391e63	2026-06-03	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	HyVee Inc	fd22d4df-9679-4c2d-9bc4-3619288fb4cc	2026-02-01	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	Kroger Company	083841e8-482d-4e5b-90ab-1139b576d691	2025-03-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	54fd9f84-9c67-4846-b79d-eb9e6720a315	2025-03-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Signature Care Omeprazole	OMEPRAZOLE	Safeway	c76c4235-92d4-4384-8ddc-ceed0b928c48	2025-03-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
berkley and jensen omeprazole	OMEPRAZOLE	BJWC	1729c60d-3475-45cd-b192-f88438403d1a	2025-03-06	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Omeprazole	OMEPRAZOLE	CVS Pharmacy	01bde9ca-0114-426d-8188-c55aefaa0961	2025-03-05	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	436c5ea1-c5ee-481f-803d-439f65873b1c	2025-01-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
up and up omeprazole	OMEPRAZOLE	Target Corporation	8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56	2025-01-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
DG health omperazole	OMEPRAZOLE	Dolgencorp Inc	99fdfeed-6828-4bf6-bb81-cd29a4ec610b	2025-01-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	H E B	344b5548-e5c0-45bf-bc3f-73af50bd5913	2025-01-30	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Basic Care Omeprazole	OMEPRAZOLE	Amazon.com Services LLC	87a2aa9b-c681-41c7-8a59-b359efd443cb	2025-01-22	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
good sense omeprazole	OMEPRAZOLE	L. Perrigo Company	dcd93796-8904-415d-a379-c4ea590cf544	2025-01-22	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	Walgreen Company	064f048c-eddd-4370-9ee4-706f9f00c8d2	2025-01-22	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Leader Omeprazole	OMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a	2024-11-26	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Omeprazole	OMEPRAZOLE	Meijer Distribution Inc	d54e1097-bd56-4371-8e59-8ceab1a5e824	2024-07-12	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	78743f3b-257e-49df-98cd-6cc0e1b4e370	2023-08-16	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400

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
55319-191-74	55319019174	14 BLISTER PACK in 1 CARTON (55319-191-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	14 blister pack	2019-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Family Dollar Services, Inc. Omeprazole Drug Facts	Family Dollar Services Inc	2019-06-20	HUMAN OTC DRUG LABEL	2