Home NDC 65649-303-03 XIFAXAN
Product NDC 65649-303
Requested package NDC 65649-303-03
11-digit product format 656490303
Labeler code 65649
Product ID 65649-303_b2e9bb84-e97e-4e7e-8a23-425418b4374d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rifaximin
Dosage form TABLET
Route ORAL
Labeler Salix Pharmaceuticals, Inc.
Application NDA021361
Marketing category NDA
Marketing start 2010-05-01
Substance RIFAXIMIN
Active strength 550 mg/1
Pharmacologic classes Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing 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 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 Product TE source text 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…
Additional Listing Data#
Finished product Yes
Brand name base XIFAXAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFAXIMIN 550 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L36O5T016N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 429662 Internal RxNorm lookup 539789 Internal RxNorm lookup 856664 Internal RxNorm lookup 856666 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIFAXIMIN ACTIVE INGREDIENT L36O5T016N XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 RIFAXIMIN ACTIVE MOIETY L36O5T016N XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 GLYCERYL PALMITOSTEARATE INACTIVE INGREDIENT GSY51O183C XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 TALC INACTIVE INGREDIENT 7SEV7J4R1U XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 23 RIFAXIMIN ACTIVE INGREDIENT L36O5T016N XIFAXAN (RIFAXIMIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 RIFAXIMIN ACTIVE MOIETY L36O5T016N XIFAXAN (RIFAXIMIN) TABLET [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65649-303 XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.] 48 Current NDC, Legacy NDC, 9 package rows 20241103_c5e8e2fd-7087-4b78-9181-cc259c0be2f1.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65649-303-03 65649030303 6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK 6 blister pack 2010-05-01 0000-00-00 No No Current