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XIFAXAN

These highlights do not include all the information needed to use XIFAXAN safely and effectively. See full prescribing information for XIFAXAN. XIFAXAN® (rifaximin) TabletsInitial 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.

Approved
Approval ID

523f0320-cc73-445a-a48d-7a181c182307

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

RIFAXIMIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6154
Application NumberNDA022554
Product Classification
M
Marketing Category
C73594
G
Generic Name
RIFAXIMIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2011
FDA Product Classification

INGREDIENTS (11)

RIFAXIMINActive
Quantity: 550 mg in 1 1
Code: L36O5T016N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
GLYCERYL PALMITOSTEARATEInactive
Code: GSY51O183C
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

RIFAXIMIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5972
Application NumberNDA021361
Product Classification
M
Marketing Category
C73594
G
Generic Name
RIFAXIMIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2011
FDA Product Classification

INGREDIENTS (11)

EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERYL PALMITOSTEARATEInactive
Code: GSY51O183C
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RIFAXIMINActive
Quantity: 200 mg in 1 1
Code: L36O5T016N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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XIFAXAN - FDA Drug Approval Details