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United States · US · US:70954-036_7d0a148e-294d-4975-9937-5244473f665d

Clotrimazole

Orange BookUNIISPLATC A01AB18

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

Identification

ManufacturerNovitium Pharma LLC
CountryUS (United States)
ATC codeA01AB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095403620
    1 BOTTLE in 1 CARTON (70954-036-20) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A209815
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G07GZ97H65",
    "rxcui": "2623",
    "inchikey": "VNFPBHJOKIVQEB-UHFFFAOYSA-N",
    "display_name": "CLOTRIMAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "a6ac4020-2c67-426a-8289-7e54ce43d0c9": {
      "match": "brand_token",
      "title": "CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS PHARMA, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-20"
    }
  },
  "productid": "70954-036_7d0a148e-294d-4975-9937-5244473f665d",
  "productndc": "70954-036",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209815",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Feb 14, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOTRIMAZOLE",
  "proprietary_name": "Clotrimazole",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209815",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole topical",
  "start_marketing_date": "20190218",
  "active_numerator_strength": "10"
}

Related drugs

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