Application 021636

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	FOR SUSPENSION;ORAL	20MG/PACKET;1.68GM/PACKET	Yes	No
002	ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	FOR SUSPENSION;ORAL	40MG/PACKET;1.68GM/PACKET	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
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SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-06-15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SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-12-21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N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-06-15	`caaa826d4ba7…`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N021636-002	ZEGERID	40MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-12-21	`caaa826d4ba7…`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N021636-001	ZEGERID	20MG/PACKET;1.68GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2004-06-15	`011fe1cb6892…`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…`

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 ndc (product): 68682-990
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 ndc (product): 68012-054 ndc (product): 68012-052

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-052	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68012-054	ZEGERID	omeprazole and sodium bicarbonate	Santarus, Inc..	NDA	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-990	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-991	Omeprazole and Sodium Bicarbonate	omeprazole, sodium bicarbonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74831	SUPPL	2023-07-20
74830	SUPPL	2023-07-20
74791	SUPPL	2023-07-19
70498	SUPPL	2022-03-11
70497	SUPPL	2022-03-11
70424	SUPPL	2022-03-07
65403	SUPPL	2020-11-30
65402	SUPPL	2020-11-30
65382	SUPPL	2020-11-30
60107	SUPPL	2019-09-25
60103	SUPPL	2019-09-25
60102	SUPPL	2019-09-25
54577	SUPPL	2018-06-14
54529	SUPPL	2018-06-12
45721	SUPPL	2016-10-31
45666	SUPPL	2016-10-26
15909	SUPPL	2014-12-29
5898	SUPPL	2014-12-24
28289	SUPPL	2014-03-04
37375	SUPPL	2014-02-27
37374	SUPPL	2012-11-15
28288	SUPPL	2012-11-14
5897	SUPPL	2012-04-23
15908	SUPPL	2012-04-20
44139	ORIG	2011-12-20
37373	SUPPL	2011-12-13
28287	SUPPL	2011-12-13
37372	SUPPL	2011-05-25
5896	SUPPL	2011-05-25
15907	SUPPL	2010-09-10
28286	SUPPL	2010-09-08
15906	SUPPL	2010-08-05
5895	SUPPL	2010-01-29
42245	ORIG	2005-12-06
28285	ORIG	2004-06-16
15905	ORIG	2004-06-16