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United States · US · US:0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171
Terconazole
Orange BookUNIISPLATC G01AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG01AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107130552733 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
0KJ2VE664U
TERCONAZOLE
RxCUI 37806
Orange Book
A077553
AB
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": "0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171",
"productndc": "0713-0552",
"dosage_form": "SUPPOSITORY",
"orange_book": {
"appl_no": "077553",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Mar 9, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERCONAZOLE",
"proprietary_name": "Terconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077553",
"marketing_category": "ANDA",
"nonproprietary_name": "Terconazole",
"start_marketing_date": "20150925",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code G01AG02.
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