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United States · US · US:63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992

Terbinafine Hydrochloride

Orange BookUNIISPLATC D01AE15

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeD01AE15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6318711115
    1 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBE
  • ndc11
    6318711130
    1 TUBE in 1 CARTON (63187-111-30) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A077511
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": {
    "50750500-6cb0-62dc-e063-6294a90a15bc": {
      "match": "brand_token",
      "title": "TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-29"
    }
  },
  "productid": "63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992",
  "productndc": "63187-111",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "077511",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Jul 2, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TERBINAFINE HYDROCHLORIDE",
  "proprietary_name": "Terbinafine Hydrochloride",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA077511",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terbinafine Hydrochloride",
  "start_marketing_date": "20070702",
  "active_numerator_strength": "1"
}

Related drugs

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