Omeprazole

Product NDC: 70518-1261
11-digit product format: 705181261
Labeler code: 70518
Product ID: 70518-1261_e3b0f501-baa5-fd39-e053-2a95a90aed98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076515
Marketing category: ANDA
Marketing start: 2018-06-18
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 40 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-1261		D	Discontinued by firm	2026-08-17
excluded package	package	70518-1261	70518-1261-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-1261	70518-1261-1	D	Discontinued by firm	2026-08-17
excluded package	package	70518-1261	70518-1261-2	D	Discontinued by firm	2026-08-17
excluded package	package	70518-1261	70518-1261-3	D	Discontinued by firm	2026-08-17
excluded package	package	70518-1261	70518-1261-4	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 2 · 72 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	70518-1261-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1261-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1261-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1261-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1261-1	`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	70518-1261-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1261-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1261-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1261-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1261-1	`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	70518-1261-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1261-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1261-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1261-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1261-1	`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	70518-1261-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1261-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1261-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1261-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1261-1	`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	70518-1261-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1261-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1261-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1261-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1261-1	`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	70518-1261-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1261-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1261-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1261-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1261-1	`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	70518-1261-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1261-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1261-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1261-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1261-1	`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	70518-1261-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1261-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1261-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1261-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1261-1	`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	70518-1261-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1261-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1261-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1261-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1261-1	`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	70518-1261-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1261-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1261-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1261-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1261-1	`ad56d346431e…`	`cc804d4bbf1e…`

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
A076515-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076515-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076515-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076515-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076515-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076515-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076515-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076515-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076515-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076515-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076515-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076515-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076515-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076515-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076515-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076515-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076515-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076515-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076515-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076515-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076515-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076515-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076515-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076515-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076515-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076515-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076515-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076515-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076515-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076515-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076515-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076515-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076515-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076515-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076515-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076515-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076515-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076515-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076515-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076515-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076515-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076515-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-1261-0	2022-02-02	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-1	2022-02-02	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-2	2022-02-02	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-3	2022-02-02	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-4	2022-02-02	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-0	2022-01-28	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-1	2022-01-28	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-2	2022-01-28	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-3	2022-01-28	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-4	2022-01-28	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Sandoz Inc	5a09ce48-7139-4fc7-9b6e-439459c8e866	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076515 application number: ANDA076515

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	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1261-3	70518126103	10 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-3)	2020-09-08	0000-00-00	No	No	Current
70518-1261-4	70518126104	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-4)	2020-12-23	0000-00-00	No	No	Current