🇺🇸
United States · US · US:63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df
MONISTAT TIOCONAZOLE 1
Orange BookUNIISPLATC G01AF08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInsight Pharmaceuticals LLC
CountryUS (United States)
ATC codeG01AF08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163736413011 APPLICATOR in 1 CARTON (63736-413-01) / 4.6 g in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
S57Y5X1117
TIOCONAZOLE
RxCUI 38298
Orange Book
A075915
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S57Y5X1117",
"rxcui": "38298",
"inchikey": "QXHHHPZILQDDPS-UHFFFAOYSA-N",
"display_name": "TIOCONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd": {
"match": "brand_token",
"title": "MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]",
"spl_version": "5",
"published_date": "2026-04-20"
}
},
"productid": "63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df",
"productndc": "63736-413",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "075915",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "6.5%",
"product_no": "001",
"approval_date": "Nov 21, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "TIOCONAZOLE",
"proprietary_name": "MONISTAT TIOCONAZOLE 1",
"active_ingred_unit": "g/100g",
"application_number": "ANDA075915",
"marketing_category": "ANDA",
"nonproprietary_name": "TIOCONAZOLE",
"start_marketing_date": "20011121",
"active_numerator_strength": "6.5"
}Related drugs
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