XIFAXAN

Product NDC: 69189-0309
11-digit product format: 691890309
Labeler code: 69189
Product ID: 69189-0309_36bc6a96-544d-4b0b-937d-323e308da080
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rifaximin
Dosage form: TABLET
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA021361
Marketing category: NDA
Marketing start: 2015-05-07
Marketing end: 0000-00-00
Substance: RIFAXIMIN
Active strength: 200 mg/1
Pharmacologic classes: Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69189-0309		I	Inactivated by FDA		2026-08-03
excluded package	package	69189-0309	69189-0309-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69189-0309-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69189-0309-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69189-0309-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69189-0309-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69189-0309-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69189-0309-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-0309-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-0309-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-0309-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-0309-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-0309-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-0309-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-0309-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-0309-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-0309-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-0309-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-0309-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69189-0309-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69189-0309-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69189-0309-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69189-0309-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-0309-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-0309-1	2020-01-31	C162847	48780-1	9d75b9d0-d9cc-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use XIFAXAN safely and effectively. See full prescribing information for XIFAXAN. XIFAXAN ® (rifaximin) tablets, for oral use Initial U.S. Approval: 2004 To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-0309-1	XIFAXAN	1 in 1 DOSE PACK	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-0309	XIFAXAN (RIFAXIMIN) TABLET [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20170414_e2991a17-fa65-49bd-a5e3-c41f2179dd9e.zip

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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L36O5T016N	RIFAXIMIN	80621-81-4	RIFAXIMIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
429662	rifAXIMin 200 MG Oral Tablet	PSN	e2991a17-fa65-49bd-a5e3-c41f2179dd9e	1
539789	XIFAXAN 200 MG Oral Tablet	PSN	e2991a17-fa65-49bd-a5e3-c41f2179dd9e	1
539789	rifaximin 200 MG Oral Tablet [XIFAXAN]	SBD	e2991a17-fa65-49bd-a5e3-c41f2179dd9e	1
429662	rifaximin 200 MG Oral Tablet	SCD	e2991a17-fa65-49bd-a5e3-c41f2179dd9e	1
539789	Xifaxan 200 MG Oral Tablet	SY	e2991a17-fa65-49bd-a5e3-c41f2179dd9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69189-0309-1	69189030901	1 in 1 DOSE PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XIFAXAN - Avera McKennan Hospital	Avera McKennan Hospital	2017-03-15	HUMAN PRESCRIPTION DRUG LABEL	1