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United States · US · US:15370-220_5a7a78a3-12b4-43f9-9212-fc7db56ca3f3
CLOTIC (clotrimazole) otic solution
Orange BookUNIISPLATC A01AB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCarwin Pharmaceutical Associates, LLC
CountryUS (United States)
ATC codeA01AB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1115370220282 POUCH in 1 CARTON (15370-220-28) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE
- ndc1115370220991 POUCH in 1 CARTON (15370-220-99) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
N217628
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G07GZ97H65",
"rxcui": "2623",
"inchikey": "VNFPBHJOKIVQEB-UHFFFAOYSA-N",
"display_name": "CLOTRIMAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "AURICULAR (OTIC)",
"spl_meta": {
"ef0658c3-9c6b-4705-89d8-cf0644c80fcb": {
"match": "brand_token",
"title": "CLOTIC (CLOTRIMAZOLE) OTIC SOLUTION (CLOTRIMAZOLE) LIQUID [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]",
"spl_version": "1",
"published_date": "2026-03-10"
}
},
"productid": "15370-220_5a7a78a3-12b4-43f9-9212-fc7db56ca3f3",
"productndc": "15370-220",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "217628",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Sep 26, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOTRIMAZOLE",
"proprietary_name": "CLOTIC (clotrimazole) otic solution",
"active_ingred_unit": "mg/.17mL",
"application_number": "NDA217628",
"marketing_category": "NDA",
"nonproprietary_name": "clotrimazole",
"start_marketing_date": "20260219",
"active_numerator_strength": "1.7"
}Related drugs
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