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United States · US · US:49035-178_3907bb0c-b1fe-a7e5-e063-6394a90ad6d8

Butenafine Hydrochloride

Orange BookUNIISPLATC D01AE23

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

Identification

ManufacturerWal-Mart Stores Inc
CountryUS (United States)
ATC codeD01AE23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4903517808
    1 TUBE in 1 CARTON (49035-178-08) / 12 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": "49035-178_3907bb0c-b1fe-a7e5-e063-6394a90ad6d8",
  "productndc": "49035-178",
  "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": "20171116",
  "active_numerator_strength": "10"
}

Related drugs

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