NDC 65734-511

Isodine Copitos

Povidone-iodine

Isodine Copitos is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Swabplus Inc.. The primary component is Povidone-iodine.

Product ID65734-511_4edad3eb-85be-41d6-8965-1859bddc3576
NDC65734-511
Product TypeHuman Otc Drug
Proprietary NameIsodine Copitos
Generic NamePovidone-iodine
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2008-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameSwabplus Inc.
Substance NamePOVIDONE-IODINE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 65734-511-72

72 APPLICATOR in 1 PACKAGE (65734-511-72) > .15 mL in 1 APPLICATOR (65734-511-00)
Marketing Start Date2008-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65734-511-72 [65734051172]

Isodine Copitos SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-06-01
Inactivation Date2020-01-31

NDC 65734-511-00 [65734051100]

Isodine Copitos SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-23

Drug Details

Active Ingredients

IngredientStrength
POVIDONE-IODINE10 mg/mL

OpenFDA Data

SPL SET ID:8629d5dd-2a59-4184-89e5-d63b77e66226
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 797730
  • NDC Crossover Matching brand name "Isodine Copitos" or generic name "Povidone-iodine"

    NDCBrand NameGeneric Name
    65734-511Isodine CopitosIsodine Copitos
    0363-0939Apothecary PVP TopicalPovidone-Iodine
    17271-205BD E-Z SCRUBpovidone-iodine
    17271-245BD E-Z SCRUBpovidone-iodine
    17271-503BD E-Z ScrubPovidone-Iodine
    0065-0411Betadinepovidone-iodine
    0363-0777First Aid AntisepticPOVIDONE-IODINE
    0536-1271First Aid AntisepticPOVIDONE-IODINE
    11673-003First Aid AntisepticPOVIDONE-IODINE
    0924-8112First Aid Only Povidone-Iodine AntisepticPovidone-iodine
    0924-8113First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINE
    0924-8110First Aid Only Povidone-Iodine Prep PadPovidone-Iodine
    0113-0110fresh and purePovidone-iodine
    0404-0121Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINE
    0404-0119Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINE
    0404-0120Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINE
    0904-1102Major Povidone IodinePOVIDONE-IODINE
    0498-0118North PVP Iodine SwabsPovidone-iodine
    0869-0050Povidone Iodine Solution First Aid AntisepticPOVIDONE-IODINE
    0924-8111Povidone-Iodine PrepPOVIDONE-IODINE
    0498-0128PVP Iodine SwabsPovidone-iodine
    0132-8743Summers EvePOVIDONE-IODINE

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