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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) 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.

Approved
Approval ID

c5e8e2fd-7087-4b78-9181-cc259c0be2f1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2023

Manufacturers
FDA

Salix Pharmaceuticals, Inc.

DUNS: 793108036

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 Code65649-301
Application NumberNDA021361
Product Classification
M
Marketing Category
C73594
G
Generic Name
rifaximin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification

INGREDIENTS (11)

EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL PALMITOSTEARATEInactive
Code: GSY51O183C
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
RIFAXIMINActive
Quantity: 200 mg in 1 1
Code: L36O5T016N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
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 Code65649-303
Application NumberNDA021361
Product Classification
M
Marketing Category
C73594
G
Generic Name
rifaximin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL PALMITOSTEARATEInactive
Code: GSY51O183C
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RIFAXIMINActive
Quantity: 550 mg in 1 1
Code: L36O5T016N
Classification: ACTIB

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XIFAXAN - FDA Drug Approval Details