🇺🇸
United States · US · US:50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490
Clotrimazole Topical Solution USP, 1%
Orange BookUNIISPLATC A01AB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc
CountryUS (United States)
ATC codeA01AB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150228502081 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE
- ndc1150228502301 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE
- ndc1150228502311 BOTTLE in 1 CARTON (50228-502-31) / 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": "50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490",
"productndc": "50228-502",
"dosage_form": "SOLUTION",
"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 Topical Solution USP, 1%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216569",
"marketing_category": "ANDA",
"nonproprietary_name": "Clotrimazole Topical Solution USP, 1%",
"start_marketing_date": "20231016",
"active_numerator_strength": "10"
}Related drugs
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