Zegerid OTC

Product NDC: 11523-7265
11-digit product format: 115237265
Labeler code: 11523
Product ID: 11523-7265_9751cf45-d729-5dae-e053-2a95a90a10eb
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole and Sodium Bicarbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Bayer HealthCare LLC
Application: NDA022281
Marketing category: NDA
Marketing start: 2010-04-01
Marketing end: 2020-11-30
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 20 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11523-7265		D	Discontinued by firm	2026-08-03
excluded package	package	11523-7265	11523-7265-1	D	Discontinued by firm	2026-08-03
excluded package	package	11523-7265	11523-7265-3	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 · 36 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	11523-7265-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11523-7265-3	`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	11523-7265-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11523-7265-3	`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	11523-7265-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11523-7265-3	`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	11523-7265-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11523-7265-3	`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	11523-7265-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11523-7265-3	`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	11523-7265-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11523-7265-3	`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	11523-7265-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11523-7265-3	`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	11523-7265-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11523-7265-3	`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	11523-7265-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11523-7265-3	`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	11523-7265-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11523-7265-3	`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	11523-7265-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11523-7265-3	`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	11523-7265-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11523-7265-3	`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
N022281-001	ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL		RLD, RS	2009-12-01

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	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7265-1	EA - Each	11523-7265	836013f9-2437-4e3d-a372-17bb43fb2a6d	1	2012-07-24
11523-7265-2	EA - Each	11523-7265	7ca5ee09-f083-4aa1-ae94-d19e1e1483ff	1	2012-07-24
11523-7265-3	EA - Each	11523-7265	d0c8b903-91b2-4f89-80c2-0b2d1cdc2bd3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
Sodium Bicarbonate	ACTIVE INGREDIENT	8MDF5V39QO	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
Bicarbonate Ion	ACTIVE MOIETY	HN1ZRA3Q20	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
Omeprazole	ACTIVE MOIETY	KG60484QX9	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
FD&C blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
gelatin	INACTIVE INGREDIENT	2G86QN327L	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]	7

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
Zegerid OTC	OMEPRAZOLE, SODIUM BICARBONATE	Riley Consumer Care LLC	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	2025-12-24	Warnings	Exact identifier application applno (NDA): 022281 application number: NDA022281

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE