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United States · US · US:63629-8621_1b3a1cf8-6673-4fe7-92cb-eb2bb3a36537
CICLOPIROX
Orange BookUNIISPLATC D01AE14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AE14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163629862111 TUBE in 1 CARTON (63629-8621-1) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
19W019ZDRJ
CICLOPIROX
RxCUI 21090
Orange Book
A078266
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": "63629-8621_1b3a1cf8-6673-4fe7-92cb-eb2bb3a36537",
"productndc": "63629-8621",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "078266",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.77%",
"product_no": "001",
"approval_date": "Jan 7, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CICLOPIROX",
"proprietary_name": "CICLOPIROX",
"active_ingred_unit": "mg/g",
"application_number": "ANDA078266",
"marketing_category": "ANDA",
"nonproprietary_name": "CICLOPIROX",
"start_marketing_date": "20090107",
"active_numerator_strength": "7.7"
}Related drugs
Other records sharing ATC code D01AE14.
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