54365-400 NDC - CHLORAPREP ONE-STEP ()

Drug Information

  • Product NDC: 54365-400
  • Proprietary Name: ChloraPrep One-Step
  • Non Proprietary Name:
  • Active Ingredient(s): 20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL20 mg/mL CHLORHEXIDINE GLUCONATE; .7 mL/mL ISOPROPYL ALCOHOL
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Decreased Cell Wall Integrity [PE]

Labeler Information

Field Name Field Value
Labeler Name: CareFusion 213 LLC
Product Type:
FDA Application Number: NDA020832
Marketing Category: NDA
Start Marketing Date:1/7/2014
End Marketing Date:1/23/2014

Package Information

No. Package Code Package Description Billing Unit
154365-400-0125 POUCH in 1 CARTON (54365-400-01) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR
254365-400-0220 POUCH in 1 CARTON (54365-400-02) / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR
354365-400-0425 POUCH in 1 CARTON (54365-400-04) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
454365-400-051 APPLICATOR in 1 POUCH (54365-400-05) / 26 mL in 1 APPLICATOR
554365-400-0660 POUCH in 1 CARTON (54365-400-06) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR
654365-400-0748 POUCH in 1 CARTON (54365-400-07) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
754365-400-0840 POUCH in 1 CARTON (54365-400-08) / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
854365-400-0925 POUCH in 1 CARTON (54365-400-09) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
954365-400-1125 POUCH in 1 CARTON (54365-400-11) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR
1054365-400-1225 POUCH in 1 CARTON (54365-400-12) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
1154365-400-131 APPLICATOR in 1 POUCH (54365-400-13) / 26 mL in 1 APPLICATOR
1254365-400-141 APPLICATOR in 1 POUCH (54365-400-14) / 26 mL in 1 APPLICATOR
1354365-400-1520 POUCH in 1 CARTON (54365-400-15) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR
1454365-400-3020 POUCH in 1 CARTON (54365-400-30) / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR
1554365-400-3160 POUCH in 1 CARTON (54365-400-31) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR
1654365-400-3225 POUCH in 1 CARTON (54365-400-32) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR
1754365-400-3325 POUCH in 1 CARTON (54365-400-33) / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR
1854365-400-3425 POUCH in 1 CARTON (54365-400-34) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
1954365-400-3525 POUCH in 1 CARTON (54365-400-35) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
2054365-400-3625 POUCH in 1 CARTON (54365-400-36) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
2154365-400-371 APPLICATOR in 1 POUCH (54365-400-37) / 26 mL in 1 APPLICATOR
2254365-400-381 APPLICATOR in 1 POUCH (54365-400-38) / 26 mL in 1 APPLICATOR
2354365-400-391 APPLICATOR in 1 POUCH (54365-400-39) / 26 mL in 1 APPLICATOR

NDC Record

Field Name Field Value Definition
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/7/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE10/7/2002This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA021555This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE4/26/2002This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/23/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/14/2000This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/14/2000This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC54365-400The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEChloraPrep One-StepThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/14/2000This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020832This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECareFusion 213 LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 4/4/2025

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