🇺🇸
United States · US · US:11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36
vagisil brand vagistat
Orange BookUNIISPLATC G01AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCombe Incorporated
CountryUS (United States)
ATC codeG01AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1111509082511 TUBE in 1 CARTON (11509-0825-1) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A074760
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": {
"833a5e4d-0591-4300-8f9c-fd00ffaf6041": {
"match": "brand_token",
"title": "VAGISIL BRAND VAGISTAT (MICONAZOLE NITRATE) CREAM [COMBE INCORPORATED]",
"spl_version": "3",
"published_date": "2025-04-21"
}
},
"productid": "11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36",
"productndc": "11509-0825",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "074760",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2%",
"product_no": "001",
"approval_date": "May 15, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "MICONAZOLE NITRATE",
"proprietary_name": "vagisil brand vagistat",
"active_ingred_unit": "g/100g",
"application_number": "ANDA074760",
"marketing_category": "ANDA",
"nonproprietary_name": "Miconazole nitrate",
"start_marketing_date": "20201008",
"active_numerator_strength": "2"
}Related drugs
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