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United States · US · US:51672-1302_395de373-caf5-13e9-e063-6294a90a5684
Terconazole
Orange BookUNIISPLATC G01AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG01AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151672130201 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) / 20 g in 1 TUBE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
0KJ2VE664U
TERCONAZOLE
RxCUI 37806
Orange Book
A075953
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": "51672-1302_395de373-caf5-13e9-e063-6294a90a5684",
"productndc": "51672-1302",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "075953",
"products": [
{
"rs": true,
"rld": false,
"te_code": "BX",
"strength": "0.8%",
"product_no": "001",
"approval_date": "Apr 6, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERCONAZOLE",
"proprietary_name": "Terconazole",
"active_ingred_unit": "mg/g",
"application_number": "ANDA075953",
"marketing_category": "ANDA",
"nonproprietary_name": "Terconazole",
"start_marketing_date": "20040406",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code G01AG02.
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