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United States · US · US:51672-1318_4882ff99-b917-693b-e063-6394a90a4476

Ciclopirox Olamine

Orange BookUNIISPLATC D01AE

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD01AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5167213181
    1 TUBE in 1 CARTON (51672-1318-1) / 15 g in 1 TUBE
  • ndc11
    5167213182
    1 TUBE in 1 CARTON (51672-1318-2) / 30 g in 1 TUBE
  • ndc11
    5167213188
    1 TUBE in 1 CARTON (51672-1318-8) / 90 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A076790
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": "51672-1318_4882ff99-b917-693b-e063-6394a90a4476",
  "productndc": "51672-1318",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "076790",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Apr 12, 2005"
      }
    ],
    "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": "ANDA076790",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ciclopirox olamine",
  "start_marketing_date": "20050412",
  "active_numerator_strength": "7.7"
}

Related drugs

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