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United States · US · US:68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c
ciclopirox
Orange BookUNIISPLATC D01AE14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD01AE14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11684624553530 g in 1 TUBE (68462-455-35)
- ndc11684624554745 g in 1 TUBE (68462-455-47)
- ndc116846245594100 g in 1 TUBE (68462-455-94)
Annotations
UNII (FDA Substance ID)
19W019ZDRJ
CICLOPIROX
RxCUI 21090
Orange Book
A091595
AB
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": "68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c",
"productndc": "68462-455",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "091595",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.77%",
"product_no": "001",
"approval_date": "Feb 29, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CICLOPIROX",
"proprietary_name": "ciclopirox",
"active_ingred_unit": "mg/g",
"application_number": "ANDA091595",
"marketing_category": "ANDA",
"nonproprietary_name": "ciclopirox",
"start_marketing_date": "20120229",
"active_numerator_strength": "7.7"
}Related drugs
Other records sharing ATC code D01AE14.
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