FDA.reportPublic FDA data

XIFAXAN

Product NDC
65649-301
11-digit product format
656490301
Labeler code
65649
Product ID
65649-301_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
2004-07-25
Substance
RIFAXIMIN
Active strength
200 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XIFAXAN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIFAXIMIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL36O5T016N
Rxcui429662, 539789, 856664, 856666

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65649-301-03XIFAXAN30 in 1 BOTTLETABLET3050
65649-301-05XIFAXAN10 in 1 CARTONTABLET1050
65649-301-05XIFAXAN10 in 1 BLISTER PACKTABLET1050
65649-301-41XIFAXAN100 in 1 BOTTLETABLET10050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65649-301-03EA - Each65649-301ce0c0870-9e88-4eed-9a2a-8c1dda14adca12012-07-24
65649-301-05EA - Each65649-301a477bea5-15b9-4a4b-82cf-976e4bbd77c712012-07-24
65649-301-41EA - Each65649-301c041388c-719d-4a32-83a0-cbab95247ec912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFAXIMINACTIVE INGREDIENTL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
RIFAXIMINACTIVE MOIETYL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
GLYCERYL PALMITOSTEARATEINACTIVE INGREDIENTGSY51O183CXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
TALCINACTIVE INGREDIENT7SEV7J4R1UXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]23
RIFAXIMINACTIVE INGREDIENTL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
RIFAXIMINACTIVE INGREDIENTL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [CARILION MATERIALS MANAGEMENT]2
RIFAXIMINACTIVE MOIETYL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [PHYSICIANS TOTAL CARE, INC.]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
RIFAXIMINACTIVE INGREDIENTL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
RIFAXIMINACTIVE MOIETYL36O5T016NXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675XIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
GLYCERYL PALMITOSTEARATEINACTIVE INGREDIENTGSY51O183CXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4XIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2XIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65649-301XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]48Current NDC, Legacy NDC, 4 package rows20241103_c5e8e2fd-7087-4b78-9181-cc259c0be2f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429662rifAXIMin 200 MG Oral TabletPSNc5e8e2fd-7087-4b78-9181-cc259c0be2f150
856664rifAXIMin 550 MG Oral TabletPSNc5e8e2fd-7087-4b78-9181-cc259c0be2f150
539789XIFAXAN 200 MG Oral TabletPSNc5e8e2fd-7087-4b78-9181-cc259c0be2f150
856666XIFAXAN 550 MG Oral TabletPSNc5e8e2fd-7087-4b78-9181-cc259c0be2f150
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBDc5e8e2fd-7087-4b78-9181-cc259c0be2f150
856666rifaximin 550 MG Oral Tablet [XIFAXAN]SBDc5e8e2fd-7087-4b78-9181-cc259c0be2f150
429662rifaximin 200 MG Oral TabletSCDc5e8e2fd-7087-4b78-9181-cc259c0be2f150
856664rifaximin 550 MG Oral TabletSCDc5e8e2fd-7087-4b78-9181-cc259c0be2f150
539789Xifaxan 200 MG Oral TabletSYc5e8e2fd-7087-4b78-9181-cc259c0be2f150
856666Xifaxan 550 MG Oral TabletSYc5e8e2fd-7087-4b78-9181-cc259c0be2f150
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
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
429662rifAXIMin 200 MG Oral TabletPSN523f0320-cc73-445a-a48d-7a181c1823072
856664rifAXIMin 550 MG Oral TabletPSN523f0320-cc73-445a-a48d-7a181c1823072
539789XIFAXAN 200 MG Oral TabletPSN523f0320-cc73-445a-a48d-7a181c1823072
856666XIFAXAN 550 MG Oral TabletPSN523f0320-cc73-445a-a48d-7a181c1823072
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBD523f0320-cc73-445a-a48d-7a181c1823072
856666rifaximin 550 MG Oral Tablet [XIFAXAN]SBD523f0320-cc73-445a-a48d-7a181c1823072
429662rifaximin 200 MG Oral TabletSCD523f0320-cc73-445a-a48d-7a181c1823072
856664rifaximin 550 MG Oral TabletSCD523f0320-cc73-445a-a48d-7a181c1823072
539789Xifaxan 200 MG Oral TabletSY523f0320-cc73-445a-a48d-7a181c1823072
856666Xifaxan 550 MG Oral TabletSY523f0320-cc73-445a-a48d-7a181c1823072
429662rifAXIMin 200 MG Oral TabletPSNe2991a17-fa65-49bd-a5e3-c41f2179dd9e1
429662rifAXIMin 200 MG Oral TabletPSN8eba0d26-06de-4ceb-9f69-efadd03756331
539789XIFAXAN 200 MG Oral TabletPSNe2991a17-fa65-49bd-a5e3-c41f2179dd9e1
539789XIFAXAN 200 MG Oral TabletPSN8eba0d26-06de-4ceb-9f69-efadd03756331
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBDe2991a17-fa65-49bd-a5e3-c41f2179dd9e1
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBD8eba0d26-06de-4ceb-9f69-efadd03756331
429662rifaximin 200 MG Oral TabletSCDe2991a17-fa65-49bd-a5e3-c41f2179dd9e1
429662rifaximin 200 MG Oral TabletSCD8eba0d26-06de-4ceb-9f69-efadd03756331
539789Xifaxan 200 MG Oral TabletSYe2991a17-fa65-49bd-a5e3-c41f2179dd9e1
539789Xifaxan 200 MG Oral TabletSY8eba0d26-06de-4ceb-9f69-efadd03756331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65649-301-036564903010330 TABLET in 1 BOTTLE (65649-301-03) 30 tablet2004-07-250000-00-00NoNoCurrent
65649-301-056564903010510 in 1 CARTONHistorical
65649-301-4165649030141100 in 1 BOTTLEHistorical