XIFAXAN

Product NDC
50090-2445
11-digit product format
500902445
Labeler code
50090
Product ID
50090-2445_ea4a4cc3-d11c-46d6-aa97-d65eef8406dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifaximin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021361
Marketing category
NDA
Marketing start
2004-07-25
Substance
RIFAXIMIN
Active strength
200 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021361-001XIFAXANRIFAXIMIN200MGTABLET / ORALRLD, RS2004-05-25
N021361-002XIFAXANRIFAXIMIN550MGTABLET / ORALABRLD, RS2010-03-24

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021361-001107037632026-02-27U-28482020-07-14
N021361-00185189492026-02-27Drug product2013-09-16
N021361-00187419042026-02-27U-2848Drug substance, Drug product2014-07-11
N021361-00192719682026-02-27Drug product2016-06-08
N021361-00181931962027-09-02Drug substance, Drug product2012-06-18
N021361-00179281152029-07-24U-11212011-04-21
N021361-002107037632026-02-27U-17082020-07-14
N021361-002107037632026-02-27U-28472020-07-14
N021361-00285189492026-02-27Drug product2013-09-16
N021361-00287419042026-02-27U-1707Drug substance, Drug product2014-07-11
N021361-00287419042026-02-27U-1708Drug substance, Drug product2014-07-11
N021361-00287419042026-02-27U-2847Drug substance, Drug product2014-07-11
N021361-00292719682026-02-27Drug product2016-06-08
N021361-00281931962027-09-02U-1707Drug substance, Drug product2012-06-18
N021361-00281931962027-09-02U-1708Drug substance, Drug product2012-06-18
N021361-002104563842029-02-26U-26432019-11-12
N021361-002104563842029-02-26U-26442019-11-12
N021361-002107656672029-02-26U-26432020-10-19
N021361-002107656672029-02-26U-26442020-10-19
N021361-002115649122029-02-26U-35112023-02-02
N021361-002115649122029-02-26U-35122023-02-02
N021361-002117795712029-02-26U-37062023-10-23
N021361-00283095692029-07-18U-1707Delist requested2015-06-18
N021361-00283095692029-07-18U-1708Delist requested2015-06-18
N021361-002103148282029-07-24U-14812019-07-01
N021361-002103353972029-07-24U-25792019-07-24
N021361-002107096942029-07-24U-25792020-07-23
N021361-00288290172029-07-24U-15622014-09-09
N021361-00289462522029-07-24U-14812015-02-03
N021361-00294211952029-07-24U-14812016-10-11
N021361-00296298282029-07-24U-19942017-04-27
N021361-00286425732029-10-02U-1481
N021361-00289693982029-10-02U-14812015-03-04

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-25782e0a99824c…
2021-12-28 21:50 UTC2021-12N021361-002XIFAXAN550MGTABLET / ORALRLD, RS2010-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021361-001XIFAXAN200MGTABLET / ORALRLD, RS2004-05-2587673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021361-002AB1a50c72e98297…

Observed Orange Book patent history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021361-001107037632026-02-27U-28482020-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00185189492026-02-27Drug product2013-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00187419042026-02-27U-2848Drug substance, Drug product2014-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00192719682026-02-27Drug product2016-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00181931962027-09-02Drug substance, Drug product2012-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00179281152029-07-24U-11212011-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002107037632026-02-27U-28472020-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002107037632026-02-27U-17082020-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00285189492026-02-27Drug product2013-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00287419042026-02-27U-1708Drug substance, Drug product2014-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00287419042026-02-27U-1707Drug substance, Drug product2014-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00287419042026-02-27U-2847Drug substance, Drug product2014-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00292719682026-02-27Drug product2016-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00281931962027-09-02U-1707Drug substance, Drug product2012-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00281931962027-09-02U-1708Drug substance, Drug product2012-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002104563842029-02-26U-26432019-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002104563842029-02-26U-26442019-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002107656672029-02-26U-26442020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002107656672029-02-26U-26432020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002115649122029-02-26U-35112023-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002115649122029-02-26U-35122023-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002117795712029-02-26U-37062023-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00283095692029-07-18U-1708Delist requested2015-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00283095692029-07-18U-1707Delist requested2015-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002103148282029-07-24U-14812019-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002103353972029-07-24U-25792019-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-002107096942029-07-24U-25792020-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00288290172029-07-24U-15622014-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00289462522029-07-24U-14812015-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00294211952029-07-24U-14812016-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00296298282029-07-24U-19942017-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00286425732029-10-02U-1481011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021361-00289693982029-10-02U-14812015-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-00179065422025-06-01Drug substance, Drug product2011-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-001107037632026-02-27U-28482020-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-00185189492026-02-27Drug product2013-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-00187419042026-02-27U-2848Drug substance, Drug product2014-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-00192719682026-02-27Drug product2016-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-00181931962027-09-02Drug substance, Drug product2012-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021361-00179281152029-07-24U-11212011-04-2131067a03dcf5…

Additional Listing Data#

Finished product
Yes
Brand name base
XIFAXAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIFAXIMIN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L36O5T016NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
429662Internal RxNorm lookup
539789Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f73acb74-e930-4414-81e9-d2a01db36e30Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2445-0XIFAXAN9 in 1 BOTTLETABLET98

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2445-0EA - Each50090-2445e94a8f1d-637a-4799-abbd-25dae8a5d1b312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2445XIFAXAN (RIFAXIMIN) TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20230208_f73acb74-e930-4414-81e9-d2a01db36e30.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIFAXANRIFAXIMINCardinal Health 107, LLC7afafa63-3236-4212-9589-045db6b01c0b2025-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021361
application number: NDA021361
XIFAXANRIFAXIMINSalix Pharmaceuticals, Inc.c5e8e2fd-7087-4b78-9181-cc259c0be2f12025-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 021361
application number: NDA021361
XIFAXANRIFAXIMINA-S Medication Solutionsf73acb74-e930-4414-81e9-d2a01db36e302023-02-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021361
application number: NDA021361
ndc (product): 50090-2445

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429662rifAXIMin 200 MG Oral TabletPSNf73acb74-e930-4414-81e9-d2a01db36e308
539789XIFAXAN 200 MG Oral TabletPSNf73acb74-e930-4414-81e9-d2a01db36e308
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBDf73acb74-e930-4414-81e9-d2a01db36e308
429662rifaximin 200 MG Oral TabletSCDf73acb74-e930-4414-81e9-d2a01db36e308
539789Xifaxan 200 MG Oral TabletSYf73acb74-e930-4414-81e9-d2a01db36e308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2445-0500902445009 TABLET in 1 BOTTLE (50090-2445-0) 9 tablet2016-08-080000-00-00NoNoCurrent