Omeprazole and Sodium Bicarbonate

Product NDC: 68682-104
11-digit product format: 686820104
Labeler code: 68682
Product ID: 68682-104_a52d487d-f07a-42f9-998c-c68fa2e1d9c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole, sodium bicarbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: NDA021849
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2006-02-27
Marketing end: 0000-00-00
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 40 mg/1; mg/1
Pharmacologic classes: Alkalinizing Activity [MoA], 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68682-104		D	Discontinued by firm		2026-10-12
excluded package	package	68682-104	68682-104-30	D	Discontinued by firm		2026-10-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021849-001	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27
N021849-002	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL		RLD	2006-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	N021849-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021849-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021849-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021849-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021849-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021849-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021849-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021849-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021849-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021849-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021849-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021849-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68682-104-30	Omeprazole and Sodium Bicarbonate	30 in 1 BOTTLE	CAPSULE	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-104-30	EA - Each	68682-104	734009f2-c8fc-4242-8cd4-d50fbe247f98	1	2015-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-104	OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [OCEANSIDE PHARMACEUTICALS]	14	Legacy NDC, 1 package rows	20250504_c26b6893-8264-4d4a-ac7e-1ddda933451e.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
753562	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	PSN	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
753557	omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	PSN	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
753562	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	SCD	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
616541	omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
753557	omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	SCD	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
616539	Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule	SY	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
753562	Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension	SY	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
616541	Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule	SY	c26b6893-8264-4d4a-ac7e-1ddda933451e	14
753557	Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension	SY	c26b6893-8264-4d4a-ac7e-1ddda933451e	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-104-30	68682010430	30 CAPSULE in 1 BOTTLE (68682-104-30)	30 capsule	2007-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole and Sodium Bicarbonate	Oceanside Pharmaceuticals \| Patheon Inc. \| PTI Royston LLC \| Norwich Pharmaceuticals, Inc \| Bausch Health Companies, Inc.	2025-05-02	HUMAN PRESCRIPTION DRUG LABEL	14