🇺🇸
United States · US · US:36800-782_6381c9e2-ff95-42f8-8b4f-0031692f5931
Topco Miconazole 3
Orange BookUNIISPLATC G01AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeG01AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1136800782143 APPLICATOR in 1 CARTON (36800-782-14) / 5 g in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A091366
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VW4H1CYW1K",
"rxcui": "42790",
"inchikey": "MCCACAIVAXEFAL-UHFFFAOYSA-N",
"display_name": "MICONAZOLE NITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"spl_meta": {
"ecf87660-f552-1f6b-e053-2a95a90a2486": {
"match": "brand_token",
"title": "TOPCO ASSOCIATES (SELENIUM SULFIDE) SHAMPOO [TOPCO ASSOCIATES]",
"spl_version": "5",
"published_date": "2026-05-11"
}
},
"productid": "36800-782_6381c9e2-ff95-42f8-8b4f-0031692f5931",
"productndc": "36800-782",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "091366",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "4%",
"product_no": "001",
"approval_date": "Jan 15, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "MICONAZOLE NITRATE",
"proprietary_name": "Topco Miconazole 3",
"active_ingred_unit": "mg/g",
"application_number": "ANDA091366",
"marketing_category": "ANDA",
"nonproprietary_name": "miconazole nitrate",
"start_marketing_date": "20200427",
"active_numerator_strength": "40"
}Related drugs
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