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United States · US · US:45802-717_5def32af-7e22-4dbf-b0cd-aca45e2987b0

Terconazole

Orange BookUNIISPLATC G01AG02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeG01AG02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4580271708
    3 BLISTER PACK in 1 CARTON (45802-717-08) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)

Annotations

UNII (FDA Substance ID)
0KJ2VE664U
TERCONAZOLE
RxCUI 37806
Orange Book
A077149
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": "45802-717_5def32af-7e22-4dbf-b0cd-aca45e2987b0",
  "productndc": "45802-717",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "077149",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERCONAZOLE",
  "proprietary_name": "Terconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077149",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terconazole",
  "start_marketing_date": "20060828",
  "active_numerator_strength": "80"
}

Related drugs

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