Application 019810

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRILOSEC	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PRILOSEC	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PRILOSEC	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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	RLD / RS	Approval date
N019810-001	PRILOSEC	OMEPRAZOLE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14
N019810-002	PRILOSEC	OMEPRAZOLE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15
N019810-003	PRILOSEC	OMEPRAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019810-002	PRILOSEC	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019810-003	PRILOSEC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019810-001	6147103*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-001	6166213*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-001	6191148*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-001	6150380*PED	2019-05-10	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-002	6147103*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-002	6166213*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-002	6191148*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-002	6150380*PED	2019-05-10	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-003	6147103*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-003	6166213*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-003	6191148*PED	2019-04-09	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019810-003	6150380*PED	2019-05-10	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019810-001	6147103*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-001	6166213*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-001	6191148*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-001	6150380*PED	2019-05-10	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-002	6147103*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-002	6166213*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-002	6191148*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-002	6150380*PED	2019-05-10	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-003	6147103*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-003	6166213*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-003	6191148*PED	2019-04-09	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019810-003	6150380*PED	2019-05-10	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019810-001	6147103*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-001	6166213*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-001	6191148*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-001	6150380*PED	2019-05-10	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-002	6147103*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-002	6166213*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-002	6191148*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-002	6150380*PED	2019-05-10	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-003	6147103*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-003	6166213*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-003	6191148*PED	2019-04-09	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019810-003	6150380*PED	2019-05-10	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019810-001	6147103*PED	2019-04-09	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019810-001	6166213*PED	2019-04-09	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019810-001	6191148*PED	2019-04-09	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019810-001	6150380*PED	2019-05-10	Pediatric extension	`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 13 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	2024-02-27	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	1c99e189-93c0-4461-82c2-4521e6c4d514	2024-02-27	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
foster and thrive omeprazole	OMEPRAZOLE	Strategic Sourcing Services LLC	836efc63-b633-497c-ab56-76bb495bd723	2024-02-20	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aurohealth LLC	19097902-a5e6-423a-8569-31c569cd3cdb	2024-02-19	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a656a059-2b1a-44b3-85f8-af278032b54c	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a52842ac-ac9d-4344-9823-b8b2afb07903	2023-12-14	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	VALU MERCHANDISERS COMPANY	7b2d41b6-3e36-4973-b5f6-adf9b828f40d	2023-12-13	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	DISCOUNT DRUG MART	ff2c8446-9d8b-4300-b157-884b48e98bb7	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Best Choice	43ea758b-6cea-44a2-b4d6-8f99211c8826	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	RELIABLE 1 LABORATORIES LLC	f6b13640-6c71-4c3d-8eb5-c36fca201aee	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	7-Eleven	61206416-e0c1-44d7-ad35-feb629361ba9	2023-12-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8f13fd38-dc73-4072-bdc9-9474704a4121	2023-11-22	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole/Sodium Bicarbonate	OMEPRAZOLE	Strides Pharma Science Limited	cf6d293e-d70d-443e-8292-d693e93aab55	2023-09-21	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	BluePoint Laboratories	a86d52a5-15e2-012d-e053-2a95a90ac912	2023-09-13	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68	2023-09-10	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	78743f3b-257e-49df-98cd-6cc0e1b4e370	2023-08-16	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	STRATEGIC SOURCING SERVICES LLC	56380ccc-6fc2-4e1b-bd87-da24c9aa31cd	2023-08-14	Warnings	Name fallback generic name: OMEPRAZOLE
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	b6c87a6a-253a-4455-9b7d-62f506da592e	2023-08-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Proficient Rx LP	13b379ef-7982-434d-9e6b-e01cd2b398d2	2023-08-01	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	39e3b45a-8e9b-49d6-976a-6668f4e27649	2023-07-10	Warnings, Adverse reactions	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-445	Omeprazole Delayed-Release	Omeprazole	Ranbaxy Laboratories Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55458	SUPPL	2018-09-12
55457	SUPPL	2018-09-12
46476	SUPPL	2016-12-22
46492	SUPPL	2016-12-21
45716	SUPPL	2016-10-31
45656	SUPPL	2016-10-26
11734	SUPPL	2014-12-29
19246	SUPPL	2014-12-24
19245	SUPPL	2014-04-14
33972	SUPPL	2014-04-01
33973	SUPPL	2014-02-27
1637	SUPPL	2014-02-27
11733	SUPPL	2013-05-21
19244	SUPPL	2013-05-16
33971	SUPPL	2012-10-12
1636	SUPPL	2012-10-11
23139	ORIG	2012-10-03
19243	SUPPL	2012-10-02
11732	SUPPL	2012-10-01
33970	SUPPL	2012-02-06
1635	SUPPL	2012-01-24
23556	ORIG	2011-12-20
19240	SUPPL	2011-07-06
11729	SUPPL	2011-07-06
19242	SUPPL	2011-05-25
11731	SUPPL	2011-05-25
19241	SUPPL	2011-01-25
11730	SUPPL	2011-01-24
33969	SUPPL	2010-09-10
1634	SUPPL	2010-09-08
19239	SUPPL	2010-03-08
33968	SUPPL	2010-03-05
19238	SUPPL	2008-12-04
11728	SUPPL	2008-12-04
20367	SUPPL	2007-07-20
20361	SUPPL	2007-07-20
41036	SUPPL	2007-07-09
19237	SUPPL	2007-05-01
11727	SUPPL	2007-05-01
19236	SUPPL	2006-09-27
33967	SUPPL	2006-09-26
19235	SUPPL	2006-01-30
33966	SUPPL	2006-01-27
33965	SUPPL	2005-03-10
1633	SUPPL	2005-03-10
33961	SUPPL	2004-04-05
33960	SUPPL	2004-04-05
19230	SUPPL	2004-03-02
1631	SUPPL	2004-03-02
33964	SUPPL	2003-10-16
33962	SUPPL	2003-10-16
19234	SUPPL	2003-10-16
19231	SUPPL	2003-10-16
19233	SUPPL	2002-12-16
33963	SUPPL	2002-07-12
19232	SUPPL	2002-07-12
1632	SUPPL	2002-02-14
41037	SUPPL	2000-02-23
20366	SUPPL	1999-02-03
20365	SUPPL	1998-07-10
20363	SUPPL	1998-01-15
20364	SUPPL	1998-01-07
20362	SUPPL	1997-11-04