SIRTURO

Orange BookUNIISPLATC J04AK05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJanssen Products, LP

CountryUS (United States)

ATC codeJ04AK05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5967670101
188 TABLET in 1 BOTTLE (59676-701-01)

Annotations

UNII (FDA Substance ID)

P04QX2C1A5

BEDAQUILINE FUMARATE

RxCUI 1364503

Orange Book

N204384

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P04QX2C1A5",
    "rxcui": "1364503",
    "inchikey": "ZLVSPMRFRHMMOY-WWCCMVHESA-N",
    "display_name": "BEDAQUILINE FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1534c9ae-4948-4cf4-9f66-222a99db6d0e": {
      "match": "brand_token",
      "title": "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]",
      "spl_version": "33",
      "published_date": "2025-11-17"
    }
  },
  "productid": "59676-701_415acee9-3121-56fb-e063-6394a90a9d83",
  "productndc": "59676-701",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204384",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Dec 28, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "May 27, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BEDAQUILINE FUMARATE",
  "proprietary_name": "SIRTURO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204384",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bedaquiline Fumarate",
  "start_marketing_date": "20121228",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J04AK05.

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