Bedaquiline labels and packages

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Bedaquiline
SIRTURO® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Microbiology
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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

References

  1. "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]". Retrieved 23 December 2013.

Adapted from the FDA Package Insert.