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United States · US · US:85437-004_4ee1de22-cab4-606f-e063-6394a90afd63
Ertaczo
Orange BookUNIISPLATC D01AC14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoral Way Pharma, LLC
CountryUS (United States)
ATC codeD01AC14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1185437004601 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
1DV05410M5
SERTACONAZOLE NITRATE
RxCUI 236601
Orange Book
N021385
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1DV05410M5",
"rxcui": "236601",
"inchikey": "HAAITRDZHUANGT-UHFFFAOYSA-N",
"display_name": "SERTACONAZOLE NITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"c6fa8dc4-2620-474e-a9b4-6657d9cbfa96": {
"match": "brand_token",
"title": "ERTACZO (SERTACONAZOLE NITRATE) CREAM [CORAL WAY PHARMA, LLC]",
"spl_version": "2",
"published_date": "2026-04-09"
}
},
"productid": "85437-004_4ee1de22-cab4-606f-e063-6394a90afd63",
"productndc": "85437-004",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "021385",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2%",
"product_no": "001",
"approval_date": "Dec 10, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTACONAZOLE NITRATE",
"proprietary_name": "Ertaczo",
"active_ingred_unit": "mg/g",
"application_number": "NDA021385",
"marketing_category": "NDA",
"nonproprietary_name": "Sertaconazole Nitrate",
"start_marketing_date": "20251107",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code D01AC14.
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