Application 216096

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED RELEASE;ORAL	EQ 20MG BASE	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
A216096-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2022-05-24

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.

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	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`a50c72e98297…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE OMEPRAZOLE	OMEPRAZOLE	L. Perrigo Company	b840439b-540b-465a-8faa-f7b1024c628e	2026-06-29	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
OMEPRAZOLE	OMEPRAZOLE	Safeway	b3ec4a44-5643-4438-b41b-e04946436719	2026-05-18	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE	Amazon.com Services LLC	7e0d319c-6917-45c4-b7e1-e870fc3fcea5	2026-05-13	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
OMEPRAZOLE	OMEPRAZOLE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6479415a-ffb0-4d20-ad00-f091c8aaaadb	2026-03-31	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
OMEPRAZOLE	OMEPRAZOLE	Walgreen Company	97eaf0dc-380b-4039-aeb7-dde39942a9d6	2026-03-31	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE	Meijer, Inc.	47c41c68-cb20-40f0-9d85-ea8db3328478	2026-03-06	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	8edfcc08-a14e-4579-bd44-045267de5b79	2025-04-02	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
equate omeprazole	OMEPRAZOLE MAGNESIUM	WALMART INC.	6790b6c8-c258-4dfb-a400-25dc2812971f	2025-03-26	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096 ndc (product): 79903-112
basic care omeprazole	OMEPRAZOLE MAGNESIUM	Amazon.com Services LLC	a4627be3-9845-428d-b3b1-c3096ae3d9b4	2024-09-05	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	Safeway	7ae4d70f-08f1-4586-965f-5a32fbe21591	2024-06-04	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	f56ff74d-116d-4a75-87dc-41c309f03918	2024-04-15	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	Meijer, Inc.	0340ef94-d2b4-47af-a045-d0d031293984	2024-03-29	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
79903-112	equate omeprazole	Omeprazole magnesium	WALMART INC.	ANDA	Current