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United States · US · US:63629-8624_2e37887f-4db9-4162-9bae-1b4a5b3ea9a9

Ciclopirox Olamine

Orange BookUNIISPLATC D01AE

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362986241
    1 TUBE in 1 CARTON (63629-8624-1) / 15 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A077364
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": "63629-8624_2e37887f-4db9-4162-9bae-1b4a5b3ea9a9",
  "productndc": "63629-8624",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "077364",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Mar 3, 2006"
      }
    ],
    "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": "ANDA077364",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciclopirox Olamine",
  "start_marketing_date": "20060719",
  "active_numerator_strength": "7.7"
}

Related drugs

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