Application 201361

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL			2016-07-15

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201361-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL	2016-07-15	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	WALMART INC.	c24c3326-99da-4c7d-aecc-7b4a8ac3f04e	2026-03-15	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 79903-013
Omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Walgreen Company	8753a131-f8b1-48e1-993b-73c1ee635fef	2025-11-04	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 0363-0732
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	CVS Pharmacy	186732a3-13b9-4ea2-ba54-424f63298a2e	2025-11-04	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 59779-732
basic care omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Amazon.com Services LLC	4587f491-04ef-4c31-b7b6-bfafd31776fb	2025-11-04	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 72288-732
Omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	H E B	ddc8d73f-f4a1-42a7-89ee-420346820f61	2025-11-03	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 37808-732
omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Meijer Distribution Inc	bb7c1c5d-b915-42f5-a5a2-5f61b088028d	2025-09-05	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 41250-938
Zegerid OTC	OMEPRAOLE, SODIUM BICARBONATE	Riley Consumer Care LLC	8d00c19a-d86b-4a2f-8791-b320ad3ca781	2025-07-15	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361
Good Sense Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	L. Perrigo Company	bcf32242-de17-4da1-b707-4ce26262eb78	2020-11-16	Warnings	Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (product): 0113-0058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0058	Good Sense Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate	L. Perrigo Company	ANDA	Current
0113-0058	Good Sense Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate	L. Perrigo Company	ANDA	Current
0363-0732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Walgreen Company	ANDA	Current
0363-0732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Walgreen Company	ANDA	Current
0363-0732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Walgreen Company	ANDA	Current
11523-7276	Zegerid OTC	omeprazole and sodium bicarbonate	Bayer HealthCare LLC.	ANDA	Current
11523-7276	Zegerid OTC	omeprazole and sodium bicarbonate	Bayer HealthCare LLC.	ANDA	Current
11523-7276	Zegerid OTC	omeprazole and sodium bicarbonate	Bayer HealthCare LLC.	ANDA	Current
36800-732	topcare omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Topco Associates LLC	ANDA	Current
37808-732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	H E B	ANDA	Current
37808-732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	H E B	ANDA	Current
37808-732	Omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	H E B	ANDA	Current
41250-938	omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Meijer Distribution Inc	ANDA	Current
41250-938	omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Meijer Distribution Inc	ANDA	Current
41250-938	omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Meijer Distribution Inc	ANDA	Current
59779-732	Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate	CVS Pharmacy	ANDA	Current
59779-732	Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate	CVS Pharmacy	ANDA	Current
59779-732	Omeprazole and Sodium Bicarbonate	Omeprazole, sodium bicarbonate	CVS Pharmacy	ANDA	Current
72288-732	basic care omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Amazon.com Services LLC	ANDA	Current
79903-013	equate omeprazole and sodium bicarbonate	Omeprazole, sodium bicarbonate	Wal-Mart Stores Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19014	ORIG	2016-07-21
9887	ORIG	2016-07-20