NDC 59676-702

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: 59676-702_b8bfbe03-0918-4510-a80e-0ec60d4c654d
• NDC: 59676-702
• Product Type: Human Prescription Drug
• Proprietary Name: SIRTURO
• Generic Name: Bedaquiline Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2020-05-27
• Marketing Category: NDA / NDA
• Application Number: NDA204384
• Labeler Name: Janssen Products, LP
• Substance Name: BEDAQUILINE FUMARATE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Diarylquinoline Antimycobacterial [EPC],Diarylquinolines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 59676-702-60

60 TABLET in 1 BOTTLE (59676-702-60)

• Marketing Start Date: 2020-05-27
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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