Application 021849

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	20MG;1.1GM	Yes	No
002	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	CAPSULE;ORAL	40MG;1.1GM	Yes	Yes

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
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ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27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ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27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 · 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	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`caaa826d4ba7…`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N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`caaa826d4ba7…`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UTC	2026-02	N021849-001	ZEGERID	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`011fe1cb6892…`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UTC	2026-02	N021849-002	ZEGERID	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27	`011fe1cb6892…`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…`
2022-03-09 01:35 UTC	2022-03	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`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	N021849-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021849-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021849-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021849-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021849-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021849-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021849-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021849-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021849-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021849-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021849-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021849-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021849-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021849-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021849-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021849-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021849-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021849-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021849-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021849-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021849-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021849-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021849-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021849-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021849-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021849-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021849-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021849-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021849-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021849-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021849-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021849-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021849-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021849-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021849-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021849-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021849-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021849-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021849-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021849-002	AB	1	`3f0d92c62455…`

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 · 2 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	Oceanside Pharmaceuticals	c26b6893-8264-4d4a-ac7e-1ddda933451e	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021849 application number: NDA021849 ndc (product): 68682-104 ndc (product): 68682-102
ZEGERID	OMEPRAZOLE AND SODIUM BICARBONATE	Santarus, Inc..	cd6868b9-5824-442b-8d65-4db29ecb70a4	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021849 application number: NDA021849 ndc (product): 68012-104 ndc (product): 68012-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66993-412	omeprazole/sodium bicarbonate	omeprazole, sodium bicarbonate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-413	omeprazole/sodium bicarbonate	omeprazole, sodium bicarbonate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-102	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-104	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-102	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-104	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74829	SUPPL	2023-07-20
74828	SUPPL	2023-07-20
74792	SUPPL	2023-07-19
70469	SUPPL	2022-03-10
70468	SUPPL	2022-03-10
70425	SUPPL	2022-03-07
68016	SUPPL	2021-07-06
68011	SUPPL	2021-07-06
65405	SUPPL	2020-11-30
65404	SUPPL	2020-11-30
65383	SUPPL	2020-11-30
60108	SUPPL	2019-09-25
60105	SUPPL	2019-09-25
60104	SUPPL	2019-09-25
54576	SUPPL	2018-06-14
54532	SUPPL	2018-06-12
45720	SUPPL	2016-10-31
45665	SUPPL	2016-10-26
16455	SUPPL	2014-12-29
6302	SUPPL	2014-12-24
28709	SUPPL	2014-03-04
37759	SUPPL	2014-02-27
16453	SUPPL	2012-11-15
6301	SUPPL	2012-11-14
28708	SUPPL	2012-04-23
16454	SUPPL	2012-04-20
23679	ORIG	2011-12-20
37758	SUPPL	2011-12-15
28707	SUPPL	2011-12-13
21841	SUPPL	2011-10-10
28706	SUPPL	2011-05-25
16452	SUPPL	2011-05-25
16451	SUPPL	2010-09-10
6300	SUPPL	2010-09-08
6299	SUPPL	2010-01-29
21840	ORIG	2008-05-07
28705	SUPPL	2008-01-09
37757	SUPPL	2008-01-08
37756	ORIG	2006-03-03
6298	ORIG	2006-03-03