NDC 59676-701

SIRTURO

Bedaquiline Fumarate

SIRTURO is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Janssen Products, Lp. The primary component is Bedaquiline Fumarate.

• Product ID: 59676-701_129aac3c-2298-11ea-9649-576052fceab8
• NDC: 59676-701
• Product Type: Human Prescription Drug
• Proprietary Name: SIRTURO
• Generic Name: Bedaquiline Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-28
• Marketing Category: NDA / NDA
• Application Number: NDA204384
• Labeler Name: Janssen Products, LP
• Substance Name: BEDAQUILINE FUMARATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Diarylquinoline Antimycobacterial [EPC],Diarylquinolines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59676-701-01

188 TABLET in 1 BOTTLE (59676-701-01)

• Marketing Start Date: 2012-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-701-01 [59676070101]

SIRTURO TABLET

• Marketing Category: NDA
• Application Number: NDA204384
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-28

Drug Details

Active Ingredients

Ingredient	Strength
BEDAQUILINE FUMARATE	100 mg/1

OpenFDA Data

• SPL SET ID: 1534c9ae-4948-4cf4-9f66-222a99db6d0e
• Manufacturer:
  • Janssen Products, LP
• UNII:
  • P04QX2C1A5
• RxNorm Concept Unique ID - RxCUI:
  • 1364509
  • 1364515
• UPC Code:
  • 0359676701019

Pharmacological Class

• Diarylquinoline Antimycobacterial [EPC]
• Diarylquinolines [CS]

NDC Crossover Matching brand name "SIRTURO" or generic name "Bedaquiline Fumarate"

NDC	Brand Name	Generic Name
59676-701	SIRTURO	Bedaquiline Fumarate
59676-702	SIRTURO	Bedaquiline Fumarate