Omeprazole and Sodium Bicarbonate

Product NDC: 68682-991
11-digit product format: 686820991
Labeler code: 68682
Product ID: 68682-991_a52d487d-f07a-42f9-998c-c68fa2e1d9c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole, sodium bicarbonate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: NDA021636
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2004-06-15
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	68682-991		D	Discontinued by firm		2026-08-17
excluded package	package	68682-991	68682-991-30	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021636-001	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-06-15
N021636-002	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-12-21

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 · 84 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	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL		RLD	2004-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2004-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2004-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2004-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2004-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2004-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2004-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2004-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2004-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2004-06-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2004-12-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021636-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021636-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021636-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021636-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021636-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021636-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021636-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021636-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021636-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021636-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021636-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021636-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021636-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021636-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021636-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021636-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021636-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021636-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021636-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021636-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021636-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021636-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021636-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021636-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021636-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021636-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021636-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021636-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021636-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021636-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021636-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021636-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021636-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021636-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021636-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021636-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021636-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021636-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021636-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021636-002	AB	1	`3f0d92c62455…`

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
68682-991-30	Omeprazole and Sodium Bicarbonate	30 in 1 CARTON	POWDER, FOR SUSPENSION	30		14
68682-991-30	Omeprazole and Sodium Bicarbonate	1 in 1 PACKET	POWDER, FOR SUSPENSION	1		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-991	OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [OCEANSIDE PHARMACEUTICALS]	14	Legacy NDC, 2 package rows	20250504_c26b6893-8264-4d4a-ac7e-1ddda933451e.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Bryant Ranch Prepack	0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021636 application number: NDA021636
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Oceanside Pharmaceuticals	c26b6893-8264-4d4a-ac7e-1ddda933451e	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021636 application number: NDA021636 ndc (product): 68682-991
ZEGERID	OMEPRAZOLE AND SODIUM BICARBONATE	Santarus, Inc..	cd6868b9-5824-442b-8d65-4db29ecb70a4	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021636 application number: NDA021636

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
68682-991-30	68682099130	30 PACKET in 1 CARTON (68682-991-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET	30 packet	2004-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole and Sodium Bicarbonate	Bryant Ranch Prepack	2025-06-13	HUMAN PRESCRIPTION DRUG LABEL	101
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