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United States · US · US:0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963
Clotrimazole
Orange BookUNIISPLATC A01AB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmacuticals USA USA Inc.
CountryUS (United States)
ATC codeA01AB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11005441462270 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)
- ndc110054414623140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)
Annotations
UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A076387
AB
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": "ORAL; 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": "0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963",
"productndc": "0054-4146",
"dosage_form": "LOZENGE",
"orange_book": {
"appl_no": "076387",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 29, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOTRIMAZOLE",
"proprietary_name": "Clotrimazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076387",
"marketing_category": "ANDA",
"nonproprietary_name": "Clotrimazole",
"start_marketing_date": "20040729",
"active_numerator_strength": "10"
}Related drugs
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