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United States · US · US:72559-035_37a42ef8-419e-aad9-e063-6294a90a6a2a

Curist

Orange BookUNIISPLATC D01AE15

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

Identification

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

Packs · 1

  • ndc11
    7255903558
    1 TUBE in 1 CARTON (72559-035-58) / 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": {
    "f2a2a5bc-2efa-c550-e053-2a95a90a55ff": {
      "match": "brand_token",
      "title": "CURIST ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG) TABLET [LITTLE PHARMA, INC.]",
      "spl_version": "5",
      "published_date": "2026-03-09"
    }
  },
  "productid": "72559-035_37a42ef8-419e-aad9-e063-6294a90a6a2a",
  "productndc": "72559-035",
  "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": "Curist",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA077511",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terbinafine Hydrochloride",
  "start_marketing_date": "20241210",
  "active_numerator_strength": "1"
}

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