Bedaquiline labels and packages

This Medication Guide has been approved by the U.S. Food and Drug Administration

Issued: October 2013

PRINCIPAL DISPLAY PANEL – 100 mg Tablet Bottle Label

NDC 59676-701-01

Sirturo™ (bedaquiline) tablets

100 mg

Dispense Medication Guide to each patient

Attention Pharmacist: Dispense in original container. Tablets dispensed outside the original container should be stored in a tight light-resistant container with an expiration date not to exceed 3 months. Store at 25°C (77°F); Excursions permitted to 15°C-30°C (59°F – 86°F).[See USP Controlled Room Temperature].^[1]

188 Tablets

Rx only

Janssen a

Adapted from the FDA Package Insert.