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United States · US · US:50090-6562_68e187e9-f915-4585-bfcc-c78fb13cd75f

Ciclopirox

Orange BookUNIISPLATC D01AE14

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD01AE14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009065620
    1 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
19W019ZDRJ
CICLOPIROX
RxCUI 21090
Orange Book
A078172
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "19W019ZDRJ",
    "rxcui": "21090",
    "inchikey": "SCKYRAXSEDYPSA-UHFFFAOYSA-N",
    "display_name": "CICLOPIROX",
    "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": "50090-6562_68e187e9-f915-4585-bfcc-c78fb13cd75f",
  "productndc": "50090-6562",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "078172",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "8%",
        "product_no": "001",
        "approval_date": "Sep 18, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX",
  "proprietary_name": "Ciclopirox",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078172",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciclopirox",
  "start_marketing_date": "20191104",
  "active_numerator_strength": "80"
}

Related drugs

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