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United States · US · US:10819-4077_2dced465-11bf-7823-e063-6394a90a9fac

Prevantics Swabstick

Orange BookUNIISPLATC A01AB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProfessional Disposables International, Inc.
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1081940772
    500 POUCH in 1 CASE (10819-4077-2) / 1.6 mL in 1 POUCH
  • ndc11
    1081940773
    500 POUCH in 1 CASE (10819-4077-3) / 1.6 mL in 1 POUCH
  • ndc11
    1081940774
    50 POUCH in 1 BOX (10819-4077-4) / 1.6 mL in 1 POUCH (10819-4077-1)

Annotations

UNII (FDA Substance ID)
MOR84MUD8E
CHLORHEXIDINE GLUCONATE
RxCUI 20791
Orange Book
N021524
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": {
    "9841200b-d4c6-b40c-e053-2995a90a5596": {
      "match": "brand_token",
      "title": "PREVANTICS SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]",
      "spl_version": "3",
      "published_date": "2025-02-12"
    }
  },
  "productid": "10819-4077_2dced465-11bf-7823-e063-6394a90a9fac",
  "productndc": "10819-4077",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021524",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.15%;70% (1ML)",
        "product_no": "001",
        "approval_date": "Jun 3, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.15%;70% (1.6ML)",
        "product_no": "002",
        "approval_date": "Jun 3, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.15%;70% (5.1ML)",
        "product_no": "003",
        "approval_date": "Jun 3, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL",
  "proprietary_name": "Prevantics Swabstick",
  "active_ingred_unit": "mg/mL; mL/mL",
  "application_number": "NDA021524",
  "marketing_category": "NDA",
  "nonproprietary_name": "chlorhexidine gluconate and isopropyl alcohol",
  "start_marketing_date": "20200601",
  "active_numerator_strength": "31.5; .7"
}

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