Varithena

Orange BookSPL

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

Identification

ManufacturerBoston Scientific Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6063513301
1 CARTON in 1 PACKAGE (60635-133-01) / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER

Annotations

Orange Book

N205098

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "dfd6b4a0-b0dc-11e2-9e96-0800200c9a66": {
      "match": "brand_token",
      "title": "VARITHENA (POLIDOCANOL) KIT [BOSTON SCIENTIFIC CORPORATION]",
      "spl_version": "17",
      "published_date": "2026-05-25"
    }
  },
  "productid": "60635-133_5455a54e-bbb4-4c02-ab6e-e9815136548e",
  "productndc": "60635-133",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205098",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "180MG/18ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "77.5MG/7.75ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Dec 21, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Varithena",
  "active_ingred_unit": null,
  "application_number": "NDA205098",
  "marketing_category": "NDA",
  "nonproprietary_name": "polidocanol",
  "start_marketing_date": "20131125",
  "active_numerator_strength": null
}

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