FDA.reportPublic FDA data

XIFAXAN

Product NDC
68258-1107
11-digit product format
682581107
Labeler code
68258
Product ID
68258-1107_6b55d24c-094e-4ff0-80af-494574378d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIFAXIMIN
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
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
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-1107-12019-11-27C16284748780-19855d018-e357-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use XIFAXAN safely and effectively. See full prescribing information for XIFAXAN. XIFAXAN® (rifaximin) Tablets 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.
68258-1107-22019-11-27C16284748780-19855d018-e357-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use XIFAXAN safely and effectively. See full prescribing information for XIFAXAN. XIFAXAN® (rifaximin) Tablets 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.
68258-1107-42019-11-27C16284748780-19855d018-e357-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use XIFAXAN safely and effectively. See full prescribing information for XIFAXAN. XIFAXAN® (rifaximin) Tablets 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
68258-1107-1XIFAXAN10 in 1 BOTTLETABLET101
68258-1107-2XIFAXAN28 in 1 BOTTLETABLET281
68258-1107-4XIFAXAN14 in 1 BOTTLETABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-1107-1EA - Each68258-11075a33bc17-e8cc-4c74-b24a-ba13619e8fff12013-10-17
68258-1107-2EA - Each68258-1107161eb682-377d-4bd0-a3c6-beea2a8eba0212013-10-17
68258-1107-4EA - Each68258-11072fce014c-a3b3-46ae-860a-0dc7456d1c7712013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
68258-1107XIFAXAN (RIFAXIMIN) TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 3 package rows20130823_8eba0d26-06de-4ceb-9f69-efadd0375633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429662rifAXIMin 200 MG Oral TabletPSN8eba0d26-06de-4ceb-9f69-efadd03756331
539789XIFAXAN 200 MG Oral TabletPSN8eba0d26-06de-4ceb-9f69-efadd03756331
539789rifaximin 200 MG Oral Tablet [XIFAXAN]SBD8eba0d26-06de-4ceb-9f69-efadd03756331
429662rifaximin 200 MG Oral TabletSCD8eba0d26-06de-4ceb-9f69-efadd03756331
539789Xifaxan 200 MG Oral TabletSY8eba0d26-06de-4ceb-9f69-efadd03756331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-1107-16825811070110 in 1 BOTTLEHistorical
68258-1107-26825811070228 in 1 BOTTLEHistorical
68258-1107-46825811070414 in 1 BOTTLEHistorical