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United States · US · US:50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490

Clotrimazole Topical Solution USP, 1%

Orange BookUNIISPLATC A01AB18

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

Identification

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

Packs · 3

  • ndc11
    5022850208
    1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE
  • ndc11
    5022850230
    1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE
  • ndc11
    5022850231
    1 BOTTLE in 1 CARTON (50228-502-31) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A216569
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": "50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490",
  "productndc": "50228-502",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "216569",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Oct 16, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOTRIMAZOLE",
  "proprietary_name": "Clotrimazole Topical Solution USP, 1%",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216569",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole Topical Solution USP, 1%",
  "start_marketing_date": "20231016",
  "active_numerator_strength": "10"
}

Related drugs

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