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 44.

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ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27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ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2006-02-27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 2 of 3 · 88 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
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…`
2021-12-28 21:50 UTC	2021-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021849-001	ZEGERID	20MG;1.1GM	CAPSULE / ORAL	AB	RLD	2006-02-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021849-002	ZEGERID	40MG;1.1GM	CAPSULE / ORAL	AB	RLD, RS	2006-02-27	`3a93d1ddd44b…`

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…`

Reported adverse events (FAERS/openFDA)#

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

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