xifaxan

Generic: rifaximin

Labeler: salix pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xifaxan
Generic Name rifaximin
Labeler salix pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rifaximin 550 mg/1

Manufacturer
Salix Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 65649-303
Product ID 65649-303_b2e9bb84-e97e-4e7e-8a23-425418b4374d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021361
Listing Expiration 2027-12-31
Marketing Start 2010-05-01

Pharmacologic Class

Established (EPC)
rifamycin antibacterial [epc]
Chemical Structure
rifamycins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65649303
Hyphenated Format 65649-303

Supplemental Identifiers

RxCUI
429662 539789 856664 856666
UNII
L36O5T016N
NUI
N0000175500 M0019113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xifaxan (source: ndc)
Generic Name rifaximin (source: ndc)
Application Number NDA021361 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 550 mg/1
source: ndc
Packaging
  • 3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (65649-303-02)
  • 6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK
  • 3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

65649-303-01 3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK 65649-303-02 60 TABLET in 1 BOTTLE (65649-303-02) 65649-303-03 6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK 65649-303-05 3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK

Ingredients (1)

rifaximin (550 mg/1)

Linked Drug Pages (1)

XIFAXAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b2e9bb84-e97e-4e7e-8a23-425418b4374d", "openfda": {"nui": ["N0000175500", "M0019113"], "unii": ["L36O5T016N"], "rxcui": ["429662", "539789", "856664", "856666"], "spl_set_id": ["c5e8e2fd-7087-4b78-9181-cc259c0be2f1"], "pharm_class_cs": ["Rifamycins [CS]"], "pharm_class_epc": ["Rifamycin Antibacterial [EPC]"], "manufacturer_name": ["Salix Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CARTON in 1 TRAY (65649-303-01)  / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK", "package_ndc": "65649-303-01", "marketing_start_date": "20100501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65649-303-02)", "package_ndc": "65649-303-02", "marketing_start_date": "20100501"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (65649-303-03)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "65649-303-03", "marketing_start_date": "20100501"}, {"sample": false, "description": "3 CARTON in 1 TRAY (65649-303-05)  / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK", "package_ndc": "65649-303-05", "marketing_start_date": "20100501"}], "brand_name": "XIFAXAN", "product_id": "65649-303_b2e9bb84-e97e-4e7e-8a23-425418b4374d", "dosage_form": "TABLET", "pharm_class": ["Rifamycin Antibacterial [EPC]", "Rifamycins [CS]"], "product_ndc": "65649-303", "generic_name": "rifaximin", "labeler_name": "Salix Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XIFAXAN", "active_ingredients": [{"name": "RIFAXIMIN", "strength": "550 mg/1"}], "application_number": "NDA021361", "marketing_category": "NDA", "marketing_start_date": "20100501", "listing_expiration_date": "20271231"}