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United States · US · US:45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8
gynazole 1
Orange BookUNIIATC G01AF15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeG01AF15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1145802396011 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR
- ndc1145802396021 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
4805237NP5
BUTOCONAZOLE NITRATE
RxCUI 47464
Orange Book
A200923
Raw payload (JSON)
{
"unii": {
"unii": "4805237NP5",
"rxcui": "47464",
"inchikey": "ZHPWRQIPPNZNML-UHFFFAOYSA-N",
"display_name": "BUTOCONAZOLE NITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"productid": "45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8",
"productndc": "45802-396",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "200923",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "2%",
"product_no": "001",
"approval_date": "May 18, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUTOCONAZOLE NITRATE",
"proprietary_name": "gynazole 1",
"active_ingred_unit": "mg/5g",
"application_number": "ANDA200923",
"marketing_category": "ANDA",
"nonproprietary_name": "butoconazole nitrate",
"start_marketing_date": "20150429",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G01AF15.
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