🇺🇸
United States · US · US:0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897
Ciclopirox Olamine
Orange BookUNIISPLATC D01AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD01AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1107130638151 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE
- ndc1107130638181 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE
- ndc1107130638311 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
50MD4SB4AP
CICLOPIROX OLAMINE
RxCUI 52172
Orange Book
A078463
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": "0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897",
"productndc": "0713-0638",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "078463",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.77%",
"product_no": "001",
"approval_date": "Dec 20, 2010"
}
],
"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": "ANDA078463",
"marketing_category": "ANDA",
"nonproprietary_name": "Ciclopirox Olamine",
"start_marketing_date": "20070522",
"active_numerator_strength": "7.7"
}Related drugs
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