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United States · US · US:45802-400_ae67550c-f609-40a6-8f0c-8909d360de0b

Ciclopirox Olamine

Orange BookUNIISPLATC D01AE

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeD01AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4580240046
    1 BOTTLE in 1 CARTON (45802-400-46) / 60 mL in 1 BOTTLE
  • ndc11
    4580240049
    1 BOTTLE in 1 CARTON (45802-400-49) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A077676
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": "45802-400_ae67550c-f609-40a6-8f0c-8909d360de0b",
  "productndc": "45802-400",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "077676",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Dec 15, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX OLAMINE",
  "proprietary_name": "Ciclopirox Olamine",
  "active_ingred_unit": "mg/100mL",
  "application_number": "ANDA077676",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciclopirox Olamine",
  "start_marketing_date": "20061229",
  "active_numerator_strength": "7.7"
}

Related drugs

Other records sharing ATC code D01AE.

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