FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiL36O5T016N
Rxcui429662, 539789

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2445-02023-02-07C16284748780-1f386c64a-2b99-0266-e053-dadaa90a7c1aThese 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.
50090-2445-02023-01-30C16284748780-1f386c64a-2b99-0266-e053-dadaa90a7c1aThese 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 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

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