Package 59676-701-01

Brand: sirturo

Generic: bedaquiline fumarate
NDC Package

Package Facts

Identity

Package NDC 59676-701-01
Digits Only 5967670101
Product NDC 59676-701
Description

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

Marketing

Marketing Status
Marketed Since 2012-12-28
Brand sirturo
Generic bedaquiline fumarate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "415acee9-3121-56fb-e063-6394a90a9d83", "openfda": {"upc": ["0359676701019", "0359676702603"], "unii": ["P04QX2C1A5"], "rxcui": ["1364509", "1364515", "2373939", "2373941"], "spl_set_id": ["1534c9ae-4948-4cf4-9f66-222a99db6d0e"], "manufacturer_name": ["Janssen Products, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "188 TABLET in 1 BOTTLE (59676-701-01)", "package_ndc": "59676-701-01", "marketing_start_date": "20121228"}], "brand_name": "SIRTURO", "product_id": "59676-701_415acee9-3121-56fb-e063-6394a90a9d83", "dosage_form": "TABLET", "pharm_class": ["Diarylquinoline Antimycobacterial [EPC]", "Diarylquinolines [CS]"], "product_ndc": "59676-701", "generic_name": "Bedaquiline Fumarate", "labeler_name": "Janssen Products, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIRTURO", "active_ingredients": [{"name": "BEDAQUILINE FUMARATE", "strength": "100 mg/1"}], "application_number": "NDA204384", "marketing_category": "NDA", "marketing_start_date": "20121228", "listing_expiration_date": "20261231"}