NDC 54365-400

ChloraPrep One-Step

Chlorhexidine Gluconate And Isopropyl Alcohol

ChloraPrep One-Step is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Carefusion 213 Llc. The primary component is Chlorhexidine Gluconate; Isopropyl Alcohol.

Product ID54365-400_7cb2fbbd-5562-4ced-e053-2991aa0afa8d
NDC54365-400
Product TypeHuman Otc Drug
Proprietary NameChloraPrep One-Step
Generic NameChlorhexidine Gluconate And Isopropyl Alcohol
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2000-07-14
Marketing CategoryNDA / NDA
Application NumberNDA020832
Labeler NameCareFusion 213 LLC
Substance NameCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Active Ingredient Strength20 mg/mL; mL/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54365-400-08

40 POUCH in 1 CARTON (54365-400-08) > 3 APPLICATOR in 1 POUCH > 1.75 mL in 1 APPLICATOR
Marketing Start Date2009-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54365-400-07 [54365040007]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA021555
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-05-10

NDC 54365-400-05 [54365040005]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-04-26

NDC 54365-400-38 [54365040038]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-31 [54365040031]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-04 [54365040004]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2000-07-14

NDC 54365-400-33 [54365040033]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-03 [54365040003]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA021555
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-10-07

NDC 54365-400-37 [54365040037]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-11 [54365040011]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-08-18

NDC 54365-400-32 [54365040032]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-34 [54365040034]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-06 [54365040006]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-07-23

NDC 54365-400-13 [54365040013]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-08-18

NDC 54365-400-39 [54365040039]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-15 [54365040015]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-07
Marketing End Date2014-01-23

NDC 54365-400-02 [54365040002]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-04-26

NDC 54365-400-12 [54365040012]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-08-18

NDC 54365-400-35 [54365040035]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-14 [54365040014]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2000-07-14

NDC 54365-400-08 [54365040008]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA021555
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-06-10

NDC 54365-400-09 [54365040009]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-04-26

NDC 54365-400-30 [54365040030]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-36 [54365040036]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-24

NDC 54365-400-01 [54365040001]

ChloraPrep One-Step SOLUTION
Marketing CategoryNDA
Application NumberNDA020832
Product TypeHUMAN OTC DRUG
Marketing Start Date2000-07-14

Drug Details

Active Ingredients

IngredientStrength
CHLORHEXIDINE GLUCONATE20 mg/mL

OpenFDA Data

SPL SET ID:3f94d971-0d96-47a2-9117-540dfd1278a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998282
  • 858726
  • NDC Crossover Matching brand name "ChloraPrep One-Step" or generic name "Chlorhexidine Gluconate And Isopropyl Alcohol"

    NDCBrand NameGeneric Name
    54365-400ChloraPrep One-Stepchlorhexidine gluconate and isopropyl alcohol
    17518-0803M SoluPrepchlorhexidine gluconate and isopropyl alcohol
    17518-0813M SoluPrepchlorhexidine gluconate and isopropyl alcohol
    0234-0587HibistatChlorhexidine gluconate and Isopropyl alcohol
    10819-4075Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcohol
    10819-4076Prevantics Maxi Swabstickchlorhexidine gluconate and isopropyl alcohol
    10819-1080Prevantics SwabChlorhexidine Gluconate and Isopropyl Alcohol
    10819-4077Prevantics Swabstickchlorhexidine gluconate and isopropyl alcohol

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