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United States · US · US:80425-0225_2a9b7c00-167c-4da0-e063-6394a90a926d

Ciclopirox Olamine

Orange BookUNIISPLATC D01AE

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeD01AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8042502251
    30 g in 1 CARTON (80425-0225-1)

Annotations

UNII (FDA Substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A090273
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "50MD4SB4AP",
    "rxcui": "52172",
    "inchikey": "MBRHNTMUYWQHMR-UHFFFAOYSA-N",
    "display_name": "CICLOPIROX OLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "1a74ed86-997a-4b86-b54a-b2b2c94e8abb": {
      "match": "brand_token",
      "title": "CICLOPIROX OLAMINE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
      "spl_version": "14",
      "published_date": "2026-04-17"
    }
  },
  "productid": "80425-0225_2a9b7c00-167c-4da0-e063-6394a90a926d",
  "productndc": "80425-0225",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "090273",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Nov 10, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX OLAMINE",
  "proprietary_name": "Ciclopirox Olamine",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA090273",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciclopirox Olamine",
  "start_marketing_date": "20230109",
  "active_numerator_strength": "7.7"
}

Related drugs

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