FDA.reportPublic FDA data

XIFAXAN

Product NDC
68151-4980
11-digit product format
681514980
Labeler code
68151
Product ID
68151-4980_0d88990d-6f38-4813-ab36-9d859a3453d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifaximin
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021361
Marketing category
NDA
Marketing start
2004-07-25
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4980-02020-01-31C16284748780-19d75b9d0-4c3f-f424-e053-dadaa90a57ceThese 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
68151-4980-0XIFAXAN1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFAXIMINACTIVE INGREDIENTL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
RIFAXIMINACTIVE MOIETYL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675XIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
GLYCERYL PALMITOSTEARATEINACTIVE INGREDIENTGSY51O183CXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4XIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2XIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4980XIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_49df84cd-0ef6-446b-b2af-556abc665ad9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429662rifAXIMin 200 MG Oral TabletPSN49df84cd-0ef6-446b-b2af-556abc665ad93
539789XIFAXAN 200 MG Oral TabletPSN49df84cd-0ef6-446b-b2af-556abc665ad93
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBD49df84cd-0ef6-446b-b2af-556abc665ad93
429662rifaximin 200 MG Oral TabletSCD49df84cd-0ef6-446b-b2af-556abc665ad93
539789Xifaxan 200 MG Oral TabletSY49df84cd-0ef6-446b-b2af-556abc665ad93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4980-0681514980001 in 1 PACKAGEHistorical