Application 021229

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRILOSEC OTC	OMEPRAZOLE MAGNESIUM	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	Yes	Yes

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
N021229-001	PRILOSEC OTC	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2003-06-20

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021229-001	6428810	2019-11-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021229-001	6403616	2019-11-15	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021229-001	6428810	2019-11-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021229-001	6403616	2019-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021229-001	6428810	2019-11-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021229-001	6403616	2019-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021229-001	6428810	2019-11-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021229-001	6403616	2019-11-15	`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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	77ed80a2-a482-4838-ac55-4865b5c31d9f	2025-10-01	Warnings	Exact identifier application applno (NDA): 021229 application number: NDA021229 ndc (product): 37000-455
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	35a79458-79f6-44d6-b74c-b4f4aaf0dde0	2025-10-01	Warnings	Exact identifier application applno (NDA): 021229 application number: NDA021229 ndc (product): 37000-459

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
37000-455	Prilosec OTC	omeprazole magnesium	The Procter & Gamble Manufacturing Company	NDA	Current
37000-455	Prilosec OTC	omeprazole magnesium	The Procter & Gamble Manufacturing Company	NDA	Current
37000-455	Prilosec OTC	omeprazole magnesium	The Procter & Gamble Manufacturing Company	NDA	Current
37000-455	Prilosec OTC	omeprazole magnesium	The Procter & Gamble Manufacturing Company	NDA	Current
37000-459	Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	NDA	Current
37000-459	Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	NDA	Current
37000-459	Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	NDA	Current
37000-459	Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	NDA	Current
70518-2167	Prilosec OTC	omeprazole magnesium	REMEDYREPACK INC.	NDA	Current
70518-2167	Prilosec OTC	omeprazole magnesium	REMEDYREPACK INC.	NDA	Current
70518-2167	Prilosec OTC	omeprazole magnesium	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72343	SUPPL	2022-10-14
72247	SUPPL	2022-10-05
61887	SUPPL	2020-02-14
61747	SUPPL	2020-01-31
58241	SUPPL	2019-04-08
58240	SUPPL	2019-04-08
54617	SUPPL	2018-06-20
54599	SUPPL	2018-06-14
53626	SUPPL	2018-04-05
53619	SUPPL	2018-04-05
45691	SUPPL	2016-10-27
45545	SUPPL	2016-10-14
36421	SUPPL	2015-07-02
27151	SUPPL	2015-06-24
14687	SUPPL	2013-09-19
27150	SUPPL	2013-09-10
4713	SUPPL	2012-09-14
14686	SUPPL	2012-03-27
4712	SUPPL	2011-08-31
4711	SUPPL	2011-07-25
27149	SUPPL	2011-06-29
27148	SUPPL	2011-03-02
27147	SUPPL	2010-12-22
27146	SUPPL	2010-07-08
27145	SUPPL	2009-11-10
27144	SUPPL	2008-06-20
4710	SUPPL	2008-03-04
4709	SUPPL	2008-01-24
27143	SUPPL	2007-03-23
14685	SUPPL	2007-03-23
27142	SUPPL	2006-10-05
14684	SUPPL	2006-10-05
42043	ORIG	2005-04-08
36420	SUPPL	2004-12-30
4708	SUPPL	2004-12-30
27141	ORIG	2003-06-24
23636	ORIG	2003-06-20
14683	ORIG	2003-06-20