Application 020973

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACIPHEX	RABEPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ACIPHEX	RABEPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	20MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020973-001	ACIPHEX	RABEPRAZOLE SODIUM	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29
N020973-002	ACIPHEX	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020973-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020973-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020973-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020973-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020973-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020973-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020973-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020973-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020973-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020973-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020973-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020973-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020973-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020973-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020973-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020973-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020973-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020973-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020973-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020973-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020973-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020973-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020973-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020973-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020973-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020973-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020973-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020973-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020973-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020973-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020973-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020973-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020973-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020973-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020973-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020973-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020973-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020973-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020973-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020973-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020973-002	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aciphex	RABEPRAZOLE SODIUM	Waylis Therapeutics LLC	1eb38279-0237-4967-be7a-c53a826c1138	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020973 application number: NDA020973

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
62856-243	AcipHex	rabeprazole sodium	Eisai Inc.	NDA	Current
68151-3834	AcipHex	rabeprazole sodium	Carilion Materials Management	NDA	Current
69784-243	Aciphex	rabeprazole sodium	Woodward Pharma Services LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74809	SUPPL	2023-07-20
74808	SUPPL	2023-07-20
74777	SUPPL	2023-07-19
70466	SUPPL	2022-03-10
70465	SUPPL	2022-03-10
70420	SUPPL	2022-03-07
70419	SUPPL	2022-03-07
65421	SUPPL	2020-11-30
65420	SUPPL	2020-11-30
65375	SUPPL	2020-11-30
54581	SUPPL	2018-06-14
54522	SUPPL	2018-06-11
54521	SUPPL	2018-06-11
51034	SUPPL	2018-01-11
51021	SUPPL	2018-01-10
47878	SUPPL	2017-04-06
45655	SUPPL	2016-10-26
3888	SUPPL	2016-04-06
35751	SUPPL	2016-04-05
14051	SUPPL	2014-12-29
3889	SUPPL	2014-12-24
26334	SUPPL	2014-10-21
35752	SUPPL	2014-10-16
14050	SUPPL	2013-04-23
3887	SUPPL	2013-04-23
26333	SUPPL	2012-10-10
35749	SUPPL	2012-10-09
35750	SUPPL	2012-05-10
3886	SUPPL	2012-05-10
21316	SUPPL	2012-03-02
44081	ORIG	2011-12-20
14049	SUPPL	2011-05-26
26332	SUPPL	2011-05-25
14048	SUPPL	2010-09-10
3885	SUPPL	2010-09-08
24185	SUPPL	2008-08-12
3884	SUPPL	2008-07-02
14047	SUPPL	2008-06-30
41850	SUPPL	2007-07-06
35748	SUPPL	2005-06-07
26331	SUPPL	2005-06-07
3883	SUPPL	2003-08-15
21317	SUPPL	2003-04-25
14045	SUPPL	2003-04-25
35747	SUPPL	2002-11-08
26329	SUPPL	2002-11-08
3882	SUPPL	2002-09-30
26330	SUPPL	2002-09-23
3881	SUPPL	2002-05-29
26328	SUPPL	2002-02-12
14046	SUPPL	2002-02-12
35746	ORIG	1999-08-19
26327	ORIG	1999-08-19
21315	ORIG	1999-08-19
63545	SUPPL	1900-01-01
63544	SUPPL	1900-01-01
58122	ORIG	1900-01-01
58121	ORIG	1900-01-01
58120	ORIG	1900-01-01
58119	ORIG	1900-01-01
58118	ORIG	1900-01-01
58117	ORIG	1900-01-01
58116	ORIG	1900-01-01
54127	ORIG	1900-01-01
54126	ORIG	1900-01-01