NDC 69189-0309

XIFAXAN

Rifaximin

XIFAXAN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Rifaximin.

• Product ID: 69189-0309_36bc6a96-544d-4b0b-937d-323e308da080
• NDC: 69189-0309
• Product Type: Human Prescription Drug
• Proprietary Name: XIFAXAN
• Generic Name: Rifaximin
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-05-07
• Marketing Category: NDA / NDA
• Application Number: NDA021361
• Labeler Name: Avera McKennan Hospital
• Substance Name: RIFAXIMIN
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Rifamycin Antibacterial [EPC],Rifamycins [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 69189-0309-1

1 TABLET in 1 DOSE PACK (69189-0309-1)

• Marketing Start Date: 2015-05-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69189-0309-1 [69189030901]

XIFAXAN TABLET

• Marketing Category: NDA
• Application Number: NDA021361
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-05-07
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RIFAXIMIN	200 mg/1

OpenFDA Data

• SPL SET ID: e2991a17-fa65-49bd-a5e3-c41f2179dd9e
• Manufacturer:
  • Avera McKennan Hospital
• 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