NDC 55695-010

Mycobutin

Rifabutin

Mycobutin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Department Of State Health Services, Pharmacy Branch. The primary component is Rifabutin.

• Product ID: 55695-010_2dcafbab-386d-2716-e054-00144ff8d46c
• NDC: 55695-010
• Product Type: Human Prescription Drug
• Proprietary Name: Mycobutin
• Generic Name: Rifabutin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1992-12-23
• Marketing Category: NDA / NDA
• Application Number: NDA050689
• Labeler Name: Department of State Health Services, Pharmacy Branch
• Substance Name: RIFABUTIN
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 55695-010-00

100 CAPSULE in 1 BOTTLE (55695-010-00)

• Marketing Start Date: 1992-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55695-010-00 [55695001000]

Mycobutin CAPSULE

• Marketing Category: NDA
• Application Number: NDA050689
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-12-23
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RIFABUTIN	150 mg/1

OpenFDA Data

• SPL SET ID: 2e050d5e-3175-2c6d-e054-00144ff88e88
• Manufacturer:
  • Department of State Health Services, Pharmacy Branch
• UNII:
  • 1W306TDA6S
• RxNorm Concept Unique ID - RxCUI:
  • 198200
  • 103899

Pharmacological Class

• Rifamycin Antimycobacterial [EPC]
• Rifamycins [CS]

NDC Crossover Matching brand name "Mycobutin" or generic name "Rifabutin"

NDC	Brand Name	Generic Name
0013-5301	Mycobutin	rifabutin
55695-010	Mycobutin	rifabutin
10135-738	Rifabutin	Rifabutin
59762-1350	Rifabutin	rifabutin
60687-198	rifabutin	rifabutin
68180-285	rifabutin	rifabutin
70954-041	Rifabutin	Rifabutin