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United States · US · US:0168-0347_4b5df750-9341-4786-8e10-b0d6950f37ed
Terconazole
Orange BookUNIISPLATC G01AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG01AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11016803472020 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)
Annotations
UNII (FDA Substance ID)
0KJ2VE664U
TERCONAZOLE
RxCUI 37806
Orange Book
N021735
BX
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0KJ2VE664U",
"rxcui": "37806",
"inchikey": "BLSQLHNBWJLIBQ-ZEQKJWHPSA-N;BLSQLHNBWJLIBQ-OZXSUGGESA-N",
"display_name": "TERCONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"spl_meta": {
"f59448bd-f730-46d2-a785-c2d6205579ff": {
"match": "brand_token",
"title": "TERCONAZOLE VAGINAL CREAM 0.8% (TERCONAZOLE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC]",
"spl_version": "8",
"published_date": "2026-02-27"
}
},
"productid": "0168-0347_4b5df750-9341-4786-8e10-b0d6950f37ed",
"productndc": "0168-0347",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "021735",
"products": [
{
"rs": true,
"rld": true,
"te_code": "BX",
"strength": "0.8%",
"product_no": "001",
"approval_date": "Oct 1, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERCONAZOLE",
"proprietary_name": "Terconazole",
"active_ingred_unit": "mg/g",
"application_number": "NDA021735",
"marketing_category": "NDA",
"nonproprietary_name": "terconazole",
"start_marketing_date": "20050201",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code G01AG02.
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