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United States · US · US:50090-7376_91d92fb9-107b-4c54-93a9-82d636480e89

Clotrimazole

Orange BookUNIISPLATC A01AB18

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA01AB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009073760
    1 TUBE, WITH APPLICATOR in 1 CARTON (50090-7376-0) / 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": "50090-7376_91d92fb9-107b-4c54-93a9-82d636480e89",
  "productndc": "50090-7376",
  "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": "20210629",
  "active_numerator_strength": "10"
}

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