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United States · US · US:84485-3606_d3e75665-e2d4-47d9-baaa-93817b5fbf00

Lamisil AT

Orange BookUNIISPLATC D01AE15

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

Identification

ManufacturerKaro Healthcare Inc.
CountryUS (United States)
ATC codeD01AE15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8448536064
    120 g in 1 CAN (84485-3606-4)

Annotations

UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
N021124
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "012C11ZU6G",
    "rxcui": "235838",
    "inchikey": "BWMISRWJRUSYEX-SZKNIZGXSA-N",
    "display_name": "TERBINAFINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "d3e75665-e2d4-47d9-baaa-93817b5fbf00": {
      "match": "brand_token",
      "title": "LAMISIL AT (TERBINAFINE HYDROCHLORIDE) SPRAY [KARO HEALTHCARE INC.]",
      "spl_version": "1",
      "published_date": "2025-12-15"
    }
  },
  "productid": "84485-3606_d3e75665-e2d4-47d9-baaa-93817b5fbf00",
  "productndc": "84485-3606",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "021124",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Mar 17, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "002",
        "approval_date": "Mar 17, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TERBINAFINE HYDROCHLORIDE",
  "proprietary_name": "Lamisil AT",
  "active_ingred_unit": "g/100g",
  "application_number": "NDA021124",
  "marketing_category": "NDA",
  "nonproprietary_name": "terbinafine hydrochloride",
  "start_marketing_date": "20251210",
  "active_numerator_strength": "1"
}

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