chloraprep one-step

Generic: chlorhexidine gluconate and isopropyl alcohol

Labeler: carefusion 213 llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name chloraprep one-step
Generic Name chlorhexidine gluconate and isopropyl alcohol
Labeler carefusion 213 llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate 20 mg/mL, isopropyl alcohol .7 mL/mL

Manufacturer
CareFusion 213 LLC

Identifiers & Regulatory

Product NDC 54365-400
Product ID 54365-400_39077328-1d82-77ac-e063-6394a90a4d24
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021555
Listing Expiration 2026-12-31
Marketing Start 2002-10-07

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54365400
Hyphenated Format 54365-400

Supplemental Identifiers

RxCUI
858726 998282
UNII
MOR84MUD8E ND2M416302

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 chloraprep one-step (source: ndc)
Generic Name chlorhexidine gluconate and isopropyl alcohol (source: ndc)
Application Number NDA021555 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • .7 mL/mL
source: ndc
Packaging
  • 48 POUCH in 1 CARTON (54365-400-07) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
  • 40 POUCH in 1 CARTON (54365-400-08) / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
source: ndc

Packages (2)

54365-400-07 48 POUCH in 1 CARTON (54365-400-07) / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR 54365-400-08 40 POUCH in 1 CARTON (54365-400-08) / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR

Ingredients (2)

chlorhexidine gluconate (20 mg/mL) isopropyl alcohol (.7 mL/mL)

Linked Drug Pages (11)

ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9) ChloraPrep One-Step ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39077328-1d82-77ac-e063-6394a90a4d24", "openfda": {"unii": ["MOR84MUD8E", "ND2M416302"], "rxcui": ["858726", "998282"], "spl_set_id": ["f06e4f9d-6cef-b57a-e053-2a95a90a7337"], "manufacturer_name": ["CareFusion 213 LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "48 POUCH in 1 CARTON (54365-400-07)  / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR", "package_ndc": "54365-400-07", "marketing_start_date": "20050510"}, {"sample": false, "description": "40 POUCH in 1 CARTON (54365-400-08)  / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR", "package_ndc": "54365-400-08", "marketing_start_date": "20090610"}], "brand_name": "ChloraPrep One-Step", "product_id": "54365-400_39077328-1d82-77ac-e063-6394a90a4d24", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "54365-400", "generic_name": "Chlorhexidine gluconate and isopropyl alcohol", "labeler_name": "CareFusion 213 LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ChloraPrep One-Step", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "20 mg/mL"}, {"name": "ISOPROPYL ALCOHOL", "strength": ".7 mL/mL"}], "application_number": "NDA021555", "marketing_category": "NDA", "marketing_start_date": "20021007", "listing_expiration_date": "20261231"}