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United States · US · US:68788-8491_ebbd70fb-8dd2-4bc8-b814-1e346558565a

Clotrimazole

Orange BookUNIISPLATC A01AB18

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA01AB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6878884914
    1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8491-4) / 45 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A074165
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": "VAGINAL",
  "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": "68788-8491_ebbd70fb-8dd2-4bc8-b814-1e346558565a",
  "productndc": "68788-8491",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "074165",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Jul 16, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CLOTRIMAZOLE",
  "proprietary_name": "Clotrimazole",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA074165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole",
  "start_marketing_date": "20230724",
  "active_numerator_strength": "10"
}

Related drugs

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