ChloraPrep One-Step

Orange BookUNIISPLATC A01AB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCareFusion 213, LLC

CountryUS (United States)

ATC codeA01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5436540034
25 POUCH in 1 CARTON (54365-400-34) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)

MOR84MUD8E

CHLORHEXIDINE GLUCONATE

RxCUI 20791

Orange Book

N020832

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MOR84MUD8E",
    "rxcui": "20791",
    "inchikey": "YZIYKJHYYHPJIB-UUPCJSQJSA-N",
    "display_name": "CHLORHEXIDINE GLUCONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "44fe08e0-4e9c-8bd6-e063-6394a90a0e2b": {
      "match": "brand_token",
      "title": "CHLORAPREP SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]",
      "spl_version": "1",
      "published_date": "2025-12-04"
    }
  },
  "productid": "54365-400_41db8350-addc-ea0a-e063-6294a90a4a93",
  "productndc": "54365-400",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "020832",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (3ML)",
        "product_no": "001",
        "approval_date": "Jul 14, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (26ML)",
        "product_no": "002",
        "approval_date": "May 3, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (1.5ML)",
        "product_no": "003",
        "approval_date": "Apr 26, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (10.5ML)",
        "product_no": "004",
        "approval_date": "Aug 20, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (10.5ML)",
        "product_no": "005",
        "approval_date": "Apr 3, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (26ML)",
        "product_no": "006",
        "approval_date": "Nov 21, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (3ML)",
        "product_no": "007",
        "approval_date": "Oct 10, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%;70% (1ML)",
        "product_no": "008",
        "approval_date": "Oct 23, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL",
  "proprietary_name": "ChloraPrep One-Step",
  "active_ingred_unit": "mg/mL; mL/mL",
  "application_number": "NDA020832",
  "marketing_category": "NDA",
  "nonproprietary_name": "chlorhexidine gluconate and isopropyl alcohol",
  "start_marketing_date": "20190524",
  "active_numerator_strength": "20; .7"
}

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