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United States · US · US:68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c

ciclopirox

Orange BookUNIISPLATC D01AE14

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD01AE14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6846245535
    30 g in 1 TUBE (68462-455-35)
  • ndc11
    6846245547
    45 g in 1 TUBE (68462-455-47)
  • ndc11
    6846245594
    100 g in 1 TUBE (68462-455-94)

Annotations

UNII (FDA Substance ID)
19W019ZDRJ
CICLOPIROX
RxCUI 21090
Orange Book
A091595
AB
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": "68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c",
  "productndc": "68462-455",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "091595",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Feb 29, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX",
  "proprietary_name": "ciclopirox",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA091595",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ciclopirox",
  "start_marketing_date": "20120229",
  "active_numerator_strength": "7.7"
}

Related drugs

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