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United States · US · US:50090-0614_dac23c28-1694-4482-9fdb-492595e970e0

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
    5009006140
    1 TUBE in 1 CARTON (50090-0614-0) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A072641
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": "50090-0614_dac23c28-1694-4482-9fdb-492595e970e0",
  "productndc": "50090-0614",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "072641",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Dec 4, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CLOTRIMAZOLE",
  "proprietary_name": "Clotrimazole",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA072641",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole",
  "start_marketing_date": "19951204",
  "active_numerator_strength": "1"
}

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