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United States · US · US:50090-0917_36d90915-c768-4dc2-ba7f-6f8fe8764e08

Terconazole

Orange BookUNIISPLATC G01AG02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG01AG02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009009170
    1 TUBE, WITH APPLICATOR in 1 CARTON (50090-0917-0) / 45 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
0KJ2VE664U
TERCONAZOLE
RxCUI 37806
Orange Book
A076043
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": "50090-0917_36d90915-c768-4dc2-ba7f-6f8fe8764e08",
  "productndc": "50090-0917",
  "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"
}

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