Home DailyMed a477bea5-15b9-4a4b-82cf-976e4bbd77c7 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:23:24 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 78 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 2026-09-14 22:38:34 2026-08 N021361-001 XIFAXAN 200MG TABLET / ORAL RLD, RS 2004-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 XIFAXAN 550MG TABLET / ORAL AB RLD, RS 2010-03-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021361-001 XIFAXAN 200MG TABLET / ORAL RLD, RS 2004-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-002 XIFAXAN 550MG TABLET / ORAL AB RLD, RS 2010-03-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 N021361-002 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021361-002 AB 1 caaa826d4ba7…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 46 · 1,831 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021361-001 10703763 2026-02-27 U-2848 2020-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-001 8518949 2026-02-27 Drug product 2013-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-001 8741904 2026-02-27 U-2848 Drug substance, Drug product 2014-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-001 9271968 2026-02-27 Drug product 2016-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-001 8193196 2027-09-02 Drug substance, Drug product 2012-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-001 7928115 2029-07-24 U-1121 2011-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10703763 2026-02-27 U-2847 2020-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10703763 2026-02-27 U-1708 2020-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8518949 2026-02-27 Drug product 2013-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8741904 2026-02-27 U-1708 Drug substance, Drug product 2014-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8741904 2026-02-27 U-1707 Drug substance, Drug product 2014-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8741904 2026-02-27 U-2847 Drug substance, Drug product 2014-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 9271968 2026-02-27 Drug product 2016-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8193196 2027-09-02 U-1707 Drug substance, Drug product 2012-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8193196 2027-09-02 U-1708 Drug substance, Drug product 2012-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10456384 2029-02-26 U-2643 2019-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10456384 2029-02-26 U-2644 2019-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10765667 2029-02-26 U-2644 2020-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10765667 2029-02-26 U-2643 2020-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 11564912 2029-02-26 U-3511 2023-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 11564912 2029-02-26 U-3512 2023-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 11779571 2029-02-26 U-3706 2023-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8309569 2029-07-18 U-1708 Delist requested 2015-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8309569 2029-07-18 U-1707 Delist requested 2015-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10314828 2029-07-24 U-1481 2019-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10335397 2029-07-24 U-2579 2019-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 10709694 2029-07-24 U-2579 2020-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8829017 2029-07-24 U-1562 2014-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8946252 2029-07-24 U-1481 2015-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 9421195 2029-07-24 U-1481 2016-10-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 9629828 2029-07-24 U-1994 2017-04-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8642573 2029-10-02 U-1481 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021361-002 8969398 2029-10-02 U-1481 2015-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021361-001 10703763 2026-02-27 U-2848 2020-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-001 8518949 2026-02-27 Drug product 2013-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-001 8741904 2026-02-27 U-2848 Drug substance, Drug product 2014-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-001 9271968 2026-02-27 Drug product 2016-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-001 8193196 2027-09-02 Drug substance, Drug product 2012-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-001 7928115 2029-07-24 U-1121 2011-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021361-002 10703763 2026-02-27 U-2847 2020-07-14 caaa826d4ba7…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.