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
5167213046
1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6) / 45 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)

0KJ2VE664U

TERCONAZOLE

RxCUI 37806

Orange Book

A076043

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": "51672-1304_362a84ff-741f-ed45-e063-6394a90a54e7",
  "productndc": "51672-1304",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "076043",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.4%",
        "product_no": "001",
        "approval_date": "Jan 19, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERCONAZOLE",
  "proprietary_name": "Terconazole",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA076043",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terconazole",
  "start_marketing_date": "20050119",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code G01AG02.

Access this data programmatically

Query Terconazole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs