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OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019810-001	PRILOSEC	OMEPRAZOLE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14
N019810-002	PRILOSEC	OMEPRAZOLE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15
N019810-003	PRILOSEC	OMEPRAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05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N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`84e616aacf4f…`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 5 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Family Dollar (FAMILY WELLNESS)	f2195d73-1fd5-4de2-aa5c-18741d11f4fc	2025-10-30	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	e235ef89-3592-4ca1-8c13-d7ce84b1001c	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	530a8a66-48ad-474f-b170-c6fac95753ec	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	ed9895ae-3d18-434c-8b56-47bccdc8fe6d	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals, Inc.	28515ff8-379d-5356-e063-6394a90af3f3	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Major Pharmaceuticals	afda9d2c-b141-4c32-a5b4-e850974b30a3	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	2025-09-03	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3724b8f7-52ff-a5f8-e063-6294a90acf20	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
dg health omeprazole	OMEPRAZOLE	Dolgencorp, LLC	326bf21c-fad4-473e-9e7f-797319d4353a	2025-09-02	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3d6e07d1-38b1-f2ab-e063-6294a90a34ac	2025-08-28	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	bab55f83-ba03-49a0-842a-19c9976b7fe8	2025-08-28	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	5bda70ae-c3f6-450b-892f-6814795dd6ca	2025-08-18	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	8090d4c3-3184-7812-53d7-aa30e14b79d1	2025-08-10	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Golden State Medical Supply, Inc.	ded71262-d17f-3799-e053-2995a90a5427	2025-08-05	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3b19d724-821b-61dc-e063-6294a90aa4d3	2025-07-29	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3a9baece-03be-6c77-e063-6394a90a7032	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Golden State Medical Supply, Inc.	f873dc20-c817-5e4f-e053-6394a90a04f2	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Cardinal Health 107, LLC	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
omeprazole	OMEPRAZOLE	Kroger Company	da18d91c-5fe9-44d4-9d6f-602900af3f08	2025-06-04	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 · 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