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United States · US · US:16571-686_de2c09da-6280-4873-859a-80e779643612

CLOTRIMAZOLE

Orange BookUNIISPLATC A01AB18

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA01AB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1657168607
    70 LOZENGE in 1 BOTTLE (16571-686-07)
  • ndc11
    1657168614
    140 LOZENGE in 1 BOTTLE (16571-686-14)

Annotations

UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A215641
AB
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": "ORAL",
  "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": "16571-686_de2c09da-6280-4873-859a-80e779643612",
  "productndc": "16571-686",
  "dosage_form": "LOZENGE",
  "orange_book": {
    "appl_no": "215641",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 29, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOTRIMAZOLE",
  "proprietary_name": "CLOTRIMAZOLE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215641",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CLOTRIMAZOLE",
  "start_marketing_date": "20240501",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A01AB18.

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