Terconazole

Orange BookUNIISPLATC G01AG02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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

ndc11
5167213303
1 DOSE PACK in 1 CARTON (51672-1330-3) / 3 SUPPOSITORY in 1 DOSE PACK

Annotations

UNII (FDA Substance ID)

0KJ2VE664U

TERCONAZOLE

RxCUI 37806

Orange Book

A077553

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": "51672-1330_3961c135-42f6-e0a2-e063-6394a90a2e33",
  "productndc": "51672-1330",
  "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": "20070309",
  "active_numerator_strength": "80"
}

Related drugs

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