Application 021361

Type: NDA
Sponsor: SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIFAXAN	RIFAXIMIN	TABLET;ORAL	200MG	Yes	Yes
002	XIFAXAN	RIFAXIMIN	TABLET;ORAL	550MG	Yes	No

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
N021361-001	XIFAXAN	RIFAXIMIN	200MG	TABLET / ORAL		RLD, RS	2004-05-25
N021361-002	XIFAXAN	RIFAXIMIN	550MG	TABLET / ORAL	AB	RLD, RS	2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021361-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021361-001	10703763	2026-02-27	U-2848		2020-07-14
N021361-001	8518949	2026-02-27		Drug product	2013-09-16
N021361-001	8741904	2026-02-27	U-2848	Drug substance, Drug product	2014-07-11
N021361-001	9271968	2026-02-27		Drug product	2016-06-08
N021361-001	8193196	2027-09-02		Drug substance, Drug product	2012-06-18
N021361-001	7928115	2029-07-24	U-1121		2011-04-21
N021361-002	10703763	2026-02-27	U-1708		2020-07-14
N021361-002	10703763	2026-02-27	U-2847		2020-07-14
N021361-002	8518949	2026-02-27		Drug product	2013-09-16
N021361-002	8741904	2026-02-27	U-1707	Drug substance, Drug product	2014-07-11
N021361-002	8741904	2026-02-27	U-1708	Drug substance, Drug product	2014-07-11
N021361-002	8741904	2026-02-27	U-2847	Drug substance, Drug product	2014-07-11
N021361-002	9271968	2026-02-27		Drug product	2016-06-08
N021361-002	8193196	2027-09-02	U-1707	Drug substance, Drug product	2012-06-18
N021361-002	8193196	2027-09-02	U-1708	Drug substance, Drug product	2012-06-18
N021361-002	10456384	2029-02-26	U-2643		2019-11-12
N021361-002	10456384	2029-02-26	U-2644		2019-11-12
N021361-002	10765667	2029-02-26	U-2643		2020-10-19
N021361-002	10765667	2029-02-26	U-2644		2020-10-19
N021361-002	11564912	2029-02-26	U-3511		2023-02-02
N021361-002	11564912	2029-02-26	U-3512		2023-02-02
N021361-002	11779571	2029-02-26	U-3706		2023-10-23
N021361-002	8309569	2029-07-18	U-1707	Delist requested	2015-06-18
N021361-002	8309569	2029-07-18	U-1708	Delist requested	2015-06-18
N021361-002	10314828	2029-07-24	U-1481		2019-07-01
N021361-002	10335397	2029-07-24	U-2579		2019-07-24
N021361-002	10709694	2029-07-24	U-2579		2020-07-23
N021361-002	8829017	2029-07-24	U-1562		2014-09-09
N021361-002	8946252	2029-07-24	U-1481		2015-02-03
N021361-002	9421195	2029-07-24	U-1481		2016-10-11
N021361-002	9629828	2029-07-24	U-1994		2017-04-27
N021361-002	8642573	2029-10-02	U-1481
N021361-002	8969398	2029-10-02	U-1481		2015-03-04

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 · 74 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	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021361-002	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021361-001	XIFAXAN	200MG	TABLET / ORAL	RLD, RS	2004-05-25	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021361-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,765 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021361-001	10703763	2026-02-27	U-2848		2020-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-001	8518949	2026-02-27		Drug product	2013-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-001	8741904	2026-02-27	U-2848	Drug substance, Drug product	2014-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-001	9271968	2026-02-27		Drug product	2016-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-001	8193196	2027-09-02		Drug substance, Drug product	2012-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-001	7928115	2029-07-24	U-1121		2011-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10703763	2026-02-27	U-2847		2020-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10703763	2026-02-27	U-1708		2020-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8518949	2026-02-27		Drug product	2013-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8741904	2026-02-27	U-1708	Drug substance, Drug product	2014-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8741904	2026-02-27	U-1707	Drug substance, Drug product	2014-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8741904	2026-02-27	U-2847	Drug substance, Drug product	2014-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	9271968	2026-02-27		Drug product	2016-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8193196	2027-09-02	U-1707	Drug substance, Drug product	2012-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8193196	2027-09-02	U-1708	Drug substance, Drug product	2012-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10456384	2029-02-26	U-2643		2019-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10456384	2029-02-26	U-2644		2019-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10765667	2029-02-26	U-2644		2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10765667	2029-02-26	U-2643		2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	11564912	2029-02-26	U-3511		2023-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	11564912	2029-02-26	U-3512		2023-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	11779571	2029-02-26	U-3706		2023-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8309569	2029-07-18	U-1708	Delist requested	2015-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8309569	2029-07-18	U-1707	Delist requested	2015-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10314828	2029-07-24	U-1481		2019-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10335397	2029-07-24	U-2579		2019-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	10709694	2029-07-24	U-2579		2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8829017	2029-07-24	U-1562		2014-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8946252	2029-07-24	U-1481		2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	9421195	2029-07-24	U-1481		2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	9629828	2029-07-24	U-1994		2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8642573	2029-10-02	U-1481			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021361-002	8969398	2029-10-02	U-1481		2015-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	7906542	2025-06-01		Drug substance, Drug product	2011-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	10703763	2026-02-27	U-2848		2020-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	8518949	2026-02-27		Drug product	2013-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	8741904	2026-02-27	U-2848	Drug substance, Drug product	2014-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	9271968	2026-02-27		Drug product	2016-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	8193196	2027-09-02		Drug substance, Drug product	2012-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021361-001	7928115	2029-07-24	U-1121		2011-04-21	`31067a03dcf5…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XIFAXAN	RIFAXIMIN	Cardinal Health 107, LLC	7afafa63-3236-4212-9589-045db6b01c0b	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021361 application number: NDA021361 ndc (product): 55154-6777
XIFAXAN	RIFAXIMIN	Salix Pharmaceuticals, Inc.	c5e8e2fd-7087-4b78-9181-cc259c0be2f1	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021361 application number: NDA021361 ndc (product): 65649-303 ndc (product): 65649-301
XIFAXAN	RIFAXIMIN	A-S Medication Solutions	f73acb74-e930-4414-81e9-d2a01db36e30	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021361 application number: NDA021361 ndc (product): 50090-2445

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2445	XIFAXAN	rifaximin	A-S Medication Solutions	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health 107, LLC	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
55154-6777	XIFAXAN	rifaximin	Cardinal Health	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-301	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
65649-303	XIFAXAN	rifaximin	Salix Pharmaceuticals, Inc.	NDA	Current
68151-4980	XIFAXAN	rifaximin	Carilion Materials Management	NDA	Current
68258-1107	XIFAXAN	RIFAXIMIN	Dispensing Solutions, Inc.	NDA	Current
69189-0309	XIFAXAN	rifaximin	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75907	SUPPL	2023-10-24
75880	SUPPL	2023-10-20
72445	SUPPL	2022-10-21
72427	SUPPL	2022-10-20
65190	SUPPL	2020-11-12
65175	SUPPL	2020-11-10
50789	SUPPL	2017-12-20
50771	SUPPL	2017-12-19
36761	SUPPL	2015-05-29
27596	SUPPL	2015-05-28
5176	SUPPL	2014-03-14
15303	SUPPL	2014-03-13
5174	SUPPL	2010-11-18
15301	SUPPL	2010-11-17
5175	SUPPL	2010-03-08
15302	SUPPL	2010-03-05
27595	SUPPL	2007-02-12
15300	SUPPL	2007-02-02
42119	ORIG	2004-08-27
36760	ORIG	2004-06-01
5173	ORIG	2004-06-01