Application 075876

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	No	No
002	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	No	No
003	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075876-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075876-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075876-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075876-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075876-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075876-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075876-003	AB	1	`ea99ee380514…`

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 2 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Unit Dose Solutions, Inc.	557d4c2c-5541-3a51-e063-6394a90ad278	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
GOOD SENSE OMEPRAZOLE	OMEPRAZOLE	L. Perrigo Company	b840439b-540b-465a-8faa-f7b1024c628e	2026-06-29	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	d9c8a242-bdba-4f92-8629-692b47ebba21	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	e67bf2c6-0618-48e0-aa08-705501d86431	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	db9f071b-85f4-061f-e053-2995a90a3ff5	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	6a1aeb95-5760-4363-816a-fa8305979c50	2026-06-26	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	P & L Development, LLC	911a08c4-ba73-4600-a5f2-7f26ba8c8604	2026-06-25	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	1eb57c13-25ed-70bc-e063-6294a90afdac	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	QPharma Inc	50115204-74f7-17c1-e063-6394a90ab665	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	a4e92bd2-8f75-4acc-9b75-df8332bd4cc4	2026-06-04	Warnings	Name fallback generic name: OMEPRAZOLE
Berkley and Jensen Omeprazole	OMEPRAZOLE	BJWC	f74752a8-a686-4c7d-91ad-8c87c4596a7a	2026-05-21	Warnings	Name fallback generic name: OMEPRAZOLE
OMEPRAZOLE	OMEPRAZOLE	Safeway	b3ec4a44-5643-4438-b41b-e04946436719	2026-05-18	Warnings	Name fallback brand name: OMEPRAZOLE generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Amazon.com Services LLC	7e0d319c-6917-45c4-b7e1-e870fc3fcea5	2026-05-13	Warnings	Name fallback brand name: omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	QPharma Inc	f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole Delayed-Release	OMEPRAZOLE	H-E-B	448ba584-6a6e-3d85-e063-6294a90a5579	2026-04-29	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Phharmaceuticals Inc.	319d990e-161b-4c16-b026-f55c413c7e8f	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	AMERISOURCEBERGEN DRUG CORPORATION	0521c51b-d113-7e35-f1a6-c4495a2bcfcc	2026-04-17	Warnings	Name fallback brand name: Omeprazole generic name: OMEPRAZOLE
care one omeprazole	OMEPRAZOLE	American Sales Company	db2d75ea-5924-4b7f-a92d-d4847a010d52	2026-04-17	Warnings	Name fallback generic name: OMEPRAZOLE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5211	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5222	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6150	Omeprazole	omeprazole	Mylan Pharmaceuticals Inc.	ANDA	Current
10544-295	Omeprazole	omeprazole	Blenheim Pharmacal, Inc.	ANDA	Current
10544-299	Omeprazole	omeprazole	Blenheim Pharmacal, Inc.	ANDA	Current
35356-811	Omeprazole	Omeprazole	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
51079-007	Omeprazole	omeprazole	Mylan Institutional Inc.	ANDA	Current
52959-722	Omeprazole	Omeprazole	H.J. Harkins Company, Inc.	ANDA	Current
53808-0746	Omeprazole	omeprazole	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5681	Omeprazole	omeprazole	Cardinal Health	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-270	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-271	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
60429-271	Omeprazole	omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
63629-2607	Omeprazole	omeprazole	Bryant Ranch Prepack	ANDA	Current
63629-2607	Omeprazole	omeprazole	Bryant Ranch Prepack	ANDA	Current
66336-706	Omeprazole	omeprazole	Dispensing Solutions, Inc.	ANDA	Current