NDC 0013-5301

Mycobutin

Rifabutin

Mycobutin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Rifabutin.

• Product ID: 0013-5301_1847ddb3-3067-4714-9a22-1a7f735996df
• NDC: 0013-5301
• 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: Pharmacia and Upjohn Company LLC
• Substance Name: RIFABUTIN
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0013-5301-17

100 CAPSULE in 1 BOTTLE (0013-5301-17)

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

NDC SPL Data Element Entries

NDC 0013-5301-17 [00013530117]

Mycobutin CAPSULE

• Marketing Category: NDA
• Application Number: NDA050689
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1992-12-23

Drug Details

Active Ingredients

Ingredient	Strength
RIFABUTIN	150 mg/1

OpenFDA Data

• SPL SET ID: 3e1a6613-bdd3-4261-93b3-d7f5cc09064b
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 1W306TDA6S
• RxNorm Concept Unique ID - RxCUI:
  • 198200
  • 103899

Pharmacological Class

• Rifamycin Antimycobacterial [EPC]
• Rifamycins [CS]
• 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