NDC 60635-111

Varithena

Polidocanol

Varithena is a Kit in the Human Prescription Drug category. It is labeled and distributed by Biocompatibles, Inc.. The primary component is .

Product ID60635-111_2c9274b3-4b99-4d9c-b90a-7f30379eb597
NDC60635-111
Product TypeHuman Prescription Drug
Proprietary NameVarithena
Generic NamePolidocanol
Dosage FormKit
Marketing Start Date2017-12-22
Marketing CategoryNDA / NDA
Application NumberNDA205098
Labeler NameBiocompatibles, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 60635-111-01

1 CARTON in 1 PACKAGE (60635-111-01) > 1 POUCH in 1 CARTON > 1 KIT in 1 POUCH * 7.75 mL in 1 CANISTER (60635-007-01) * 303 mL in 1 CANISTER
Marketing Start Date2017-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60635-111-01 [60635011101]

Varithena KIT
Marketing CategoryNDA
Application NumberNDA205098
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-22

Drug Details

OpenFDA Data

SPL SET ID:dfd6b4a0-b0dc-11e2-9e96-0800200c9a66
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 1485070
  • 1485068
  • NDC Crossover Matching brand name "Varithena" or generic name "Polidocanol"

    NDCBrand NameGeneric Name
    60635-107Varithenapolidocanol
    60635-111Varithenapolidocanol
    60635-118Varithenapolidocanol
    60635-123Varithenapolidocanol
    60635-133Varithenapolidocanol
    46783-121AscleraPOLIDOCANOL
    46783-221AscleraPOLIDOCANOL
    67850-140AscleraPOLIDOCANOL
    67850-141AscleraPOLIDOCANOL

    Trademark Results [Varithena]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VARITHENA
    VARITHENA
    79165788 4948523 Live/Registered
    Provensis Limited
    2014-05-13
    VARITHENA
    VARITHENA
    79153260 4915907 Live/Registered
    Provensis Limited
    2014-05-13
    VARITHENA
    VARITHENA
    79139582 4638965 Live/Registered
    Provensis Limited
    2013-04-16
    VARITHENA
    VARITHENA
    79138177 4615611 Live/Registered
    Provensis Limited
    2013-04-16
    VARITHENA
    VARITHENA
    79130159 4516822 Live/Registered
    Provensis Limited
    2012-10-03

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