sirturo

Generic: bedaquiline fumarate

Labeler: janssen products, lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sirturo
Generic Name bedaquiline fumarate
Labeler janssen products, lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bedaquiline fumarate 100 mg/1

Manufacturer
Janssen Products, LP

Identifiers & Regulatory

Product NDC 59676-701
Product ID 59676-701_415acee9-3121-56fb-e063-6394a90a9d83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204384
Listing Expiration 2026-12-31
Marketing Start 2012-12-28

Pharmacologic Class

Classes
diarylquinoline antimycobacterial [epc] diarylquinolines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676701
Hyphenated Format 59676-701

Supplemental Identifiers

RxCUI
1364509 1364515 2373939 2373941
UPC
0359676701019 0359676702603
UNII
P04QX2C1A5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sirturo (source: ndc)
Generic Name bedaquiline fumarate (source: ndc)
Application Number NDA204384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 188 TABLET in 1 BOTTLE (59676-701-01)
source: ndc

Packages (1)

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

Ingredients (1)

bedaquiline fumarate (100 mg/1)

Linked Drug Pages (1)

SIRTURO ndc-match (0.9)

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"}