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United States · US · US:42192-715_955307bc-4c2a-4d14-a1de-074a36e5ad92

Ciclopirox

Orange BookUNIISPLATC D01AE14

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

Identification

ManufacturerAcella Pharmaceuticals, LLC
CountryUS (United States)
ATC codeD01AE14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4219271506
    1 BOTTLE in 1 CARTON (42192-715-06) / 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": "42192-715_955307bc-4c2a-4d14-a1de-074a36e5ad92",
  "productndc": "42192-715",
  "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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