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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
- ndc1142192715061 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
Other records sharing ATC code D01AE14.
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