NDC 68258-1107

XIFAXAN

Rifaximin

XIFAXAN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Rifaximin.

• Product ID: 68258-1107_6b55d24c-094e-4ff0-80af-494574378d75
• NDC: 68258-1107
• Product Type: Human Prescription Drug
• Proprietary Name: XIFAXAN
• Generic Name: Rifaximin
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2004-07-25
• Marketing Category: NDA / NDA
• Application Number: NDA021361
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: RIFAXIMIN
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Rifamycin Antibacterial [EPC],Rifamycins [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68258-1107-1

10 TABLET in 1 BOTTLE (68258-1107-1)

• Marketing Start Date: 2004-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-1107-2 [68258110702]

XIFAXAN TABLET

• Marketing Category: NDA
• Application Number: NDA021361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-25
• Inactivation Date: 2019-11-27

NDC 68258-1107-1 [68258110701]

XIFAXAN TABLET

• Marketing Category: NDA
• Application Number: NDA021361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-25
• Inactivation Date: 2019-11-27

NDC 68258-1107-4 [68258110704]

XIFAXAN TABLET

• Marketing Category: NDA
• Application Number: NDA021361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-25
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
RIFAXIMIN	200 mg/1

OpenFDA Data

• SPL SET ID: 8eba0d26-06de-4ceb-9f69-efadd0375633
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • L36O5T016N
• RxNorm Concept Unique ID - RxCUI:
  • 429662
  • 539789

Pharmacological Class

• Rifamycin Antibacterial [EPC]
• Rifamycins [CS]

NDC Crossover Matching brand name "XIFAXAN" or generic name "Rifaximin"

NDC	Brand Name	Generic Name
50090-2445	XIFAXAN	rifaximin
55154-6777	XIFAXAN	rifaximin
65649-301	XIFAXAN	rifaximin
65649-303	XIFAXAN	rifaximin
68151-4980	XIFAXAN	rifaximin
68258-1107	XIFAXAN	RIFAXIMIN
69189-0309	XIFAXAN	rifaximin