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United States · US · US:73581-210_459b7a6e-8c81-2084-e063-6294a90a4083

Butenafine Hydrochloride

Orange BookUNIISPLATC D01AE23

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

Identification

ManufacturerYYBA CORP
CountryUS (United States)
ATC codeD01AE23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7358121002
    1 TUBE in 1 CARTON (73581-210-02) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
R8XA2029ZI
BUTENAFINE HYDROCHLORIDE
RxCUI 236558
Orange Book
A205181
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R8XA2029ZI",
    "rxcui": "236558",
    "inchikey": "LJBSAUIFGPSHCN-UHFFFAOYSA-N",
    "display_name": "BUTENAFINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "e650d8aa-c809-42ee-a1d9-a6321d5364f5": {
      "match": "brand_token",
      "title": "BUTENAFINE HYDROCHLORIDE CREAM [YYBA CORP]",
      "spl_version": "4",
      "published_date": "2025-12-12"
    }
  },
  "productid": "73581-210_459b7a6e-8c81-2084-e063-6294a90a4083",
  "productndc": "73581-210",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "205181",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Nov 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BUTENAFINE HYDROCHLORIDE",
  "proprietary_name": "Butenafine Hydrochloride",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA205181",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butenafine Hydrochloride",
  "start_marketing_date": "20231012",
  "active_numerator_strength": "10"
}

Related drugs

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