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OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019810-001	PRILOSEC	OMEPRAZOLE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14
N019810-002	PRILOSEC	OMEPRAZOLE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1998-01-15
N019810-003	PRILOSEC	OMEPRAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1995-10-05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N019810-001	PRILOSEC	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1989-09-14	`84e616aacf4f…`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 11 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	NuCarePharmaceuticals, Inc.	4be616c4-1b9a-5654-e054-00144ff88e88	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	ad675ef6-5377-b9f2-e053-2995a90a06e9	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	6fa6afcf-33b3-3115-e053-2a91aa0abd0b	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	5564c9dc-6f99-6639-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	55a1fb3c-f040-2e39-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	1d4ecc1e-5180-f75e-e063-6394a90a51a6	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Meijer Distribution Inc	d54e1097-bd56-4371-8e59-8ceab1a5e824	2024-07-12	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Fred's, Inc.	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	CVS Pharmacy, Inc.	3349ee88-e53b-4586-8d28-20ecf8fcb1a5	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
good sense omeprazole delayed release	OMEPRAZOLE	L. Perrigo Company	38082e59-c509-4be5-b29c-33a97565df1c	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	3eb70031-6439-44cf-8056-3e2e1e4a7fa9	2024-06-27	Warnings	Name fallback generic name: OMEPRAZOLE
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	0edfa800-fb14-44dd-9c31-de930b864ef9	2024-06-25	Warnings	Name fallback generic name: OMEPRAZOLE
Omeprazole	OMEPRAZOLE	Aurobindo Pharma Limited	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	2024-06-17	Warnings, Adverse reactions	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Family Dollar Stores, LLC	6d8daf78-1672-4bbf-a022-514bf0a5ac9a	2024-06-17	Warnings	Name fallback generic name: OMEPRAZOLE
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	76b941f0-a02f-43e8-821e-09ccf675d944	2024-06-17	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	NORTHEAST PHARMA	35ceccb5-dc3d-4ee1-bdac-35cb52c22f59	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Cardinal Health	230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	Bi-Mart	419659f9-098a-4a18-8bba-cd45157bfa50	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	WALGREEN CO.	b9561780-e358-b610-e053-2a95a90af020	2024-06-15	Warnings	Name fallback generic name: OMEPRAZOLE
Acid Reducer	OMEPRAZOLE	KROGER COMPANY	eb5d02a8-4112-2066-e053-2a95a90abba3	2024-06-15	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