varithena

Generic: polidocanol

Labeler: biocompatibles, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name varithena
Generic Name polidocanol
Labeler biocompatibles, inc.
Dosage Form KIT
Manufacturer
Biocompatibles, Inc.

Identifiers & Regulatory

Product NDC 60635-133
Product ID 60635-133_ed29eb49-f0ee-4c9c-85e7-82ad430300c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205098
Listing Expiration 2026-12-31
Marketing Start 2013-11-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60635133
Hyphenated Format 60635-133

Supplemental Identifiers

RxCUI
1485068 1485070

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 varithena (source: ndc)
Generic Name polidocanol (source: ndc)
Application Number NDA205098 (source: ndc)

Resolved Composition

Strengths
  • 180 mg/18 ml
  • 10 mg/ml
  • 77.5 mg/7.75 ml
  • 1 %
  • 1.3 mg
  • 18 ml
  • 7.75 ml
source: label
Packaging
  • 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
source: ndc

Packages (1)

60635-133-01 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Varithena ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ed29eb49-f0ee-4c9c-85e7-82ad430300c8", "openfda": {"rxcui": ["1485068", "1485070"], "spl_set_id": ["dfd6b4a0-b0dc-11e2-9e96-0800200c9a66"], "manufacturer_name": ["Biocompatibles, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "60635-133-01", "marketing_start_date": "20160622"}], "brand_name": "Varithena", "product_id": "60635-133_ed29eb49-f0ee-4c9c-85e7-82ad430300c8", "dosage_form": "KIT", "product_ndc": "60635-133", "generic_name": "polidocanol", "labeler_name": "Biocompatibles, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varithena", "application_number": "NDA205098", "marketing_category": "NDA", "marketing_start_date": "20131125", "listing_expiration_date": "20261231"}