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United States · US · US:0168-0133_a42ebf09-c9f0-47b6-9a36-dcccda087c25
Clotrimazole
Orange BookUNIISPLATC A01AB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA01AB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11016801331515 g in 1 TUBE (0168-0133-15)
- ndc11016801333030 g in 1 TUBE (0168-0133-30)
- ndc11016801334645 g in 1 TUBE (0168-0133-46)
Annotations
UNII (FDA Substance ID)
G07GZ97H65
CLOTRIMAZOLE
RxCUI 2623
Orange Book
A078338
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": "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": "0168-0133_a42ebf09-c9f0-47b6-9a36-dcccda087c25",
"productndc": "0168-0133",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "078338",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Sep 2, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOTRIMAZOLE",
"proprietary_name": "Clotrimazole",
"active_ingred_unit": "mg/g",
"application_number": "ANDA078338",
"marketing_category": "ANDA",
"nonproprietary_name": "clotrimazole",
"start_marketing_date": "20080902",
"active_numerator_strength": "10"
}Related drugs
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