🇺🇸
United States · US · US:82568-0036_4bd825f4-f5e3-aab7-e063-6394a90ad6a4
CLOTRIMAZOLE
Orange BookUNIISPLATC A01AB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAARNA USA INC
CountryUS (United States)
ATC codeA01AB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1182568003611 BOTTLE in 1 CARTON (82568-0036-1) / 10 mL in 1 BOTTLE
- ndc1182568003631 BOTTLE in 1 CARTON (82568-0036-3) / 30 mL in 1 BOTTLE
- ndc1182568003662 BOTTLE in 1 CARTON (82568-0036-6) / 30 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A216569
AT
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": "TOPICAL",
"spl_meta": {
"a6ac4020-2c67-426a-8289-7e54ce43d0c9": {
"match": "brand_token",
"title": "CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS PHARMA, INC.]",
"spl_version": "15",
"published_date": "2026-05-20"
}
},
"productid": "82568-0036_4bd825f4-f5e3-aab7-e063-6394a90ad6a4",
"productndc": "82568-0036",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "216569",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "1%",
"product_no": "001",
"approval_date": "Oct 16, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOTRIMAZOLE",
"proprietary_name": "CLOTRIMAZOLE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216569",
"marketing_category": "ANDA",
"nonproprietary_name": "CLOTRIMAZOLE",
"start_marketing_date": "20231016",
"active_numerator_strength": "10"
}Related drugs
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