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United States · US · US:21922-053_c81092f6-fe1e-4f70-8699-69c4cdce214f
CICLOPIROX
Orange BookUNIISPLATC D01AE14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeD01AE14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1121922053511 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-053-51) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
19W019ZDRJ
CICLOPIROX
RxCUI 21090
Orange Book
A077687
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": "21922-053_c81092f6-fe1e-4f70-8699-69c4cdce214f",
"productndc": "21922-053",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "077687",
"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": "ANDA077687",
"marketing_category": "ANDA",
"nonproprietary_name": "ciclopirox",
"start_marketing_date": "20231109",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code D01AE14.
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