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United States · US · US:70000-0357_d5dec365-3936-4367-9df2-57a919a11eb3

Leader Tioconazole 1

Orange BookUNIISPLATC G01AF08

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeG01AF08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000003571
    1 APPLICATOR in 1 CARTON (70000-0357-1) / 4.6 g in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
S57Y5X1117
TIOCONAZOLE
RxCUI 38298
Orange Book
A075915
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S57Y5X1117",
    "rxcui": "38298",
    "inchikey": "QXHHHPZILQDDPS-UHFFFAOYSA-N",
    "display_name": "TIOCONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "12971fb2-2314-4443-bf70-b7eb5859b148": {
      "match": "brand_token",
      "title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70000-0357_d5dec365-3936-4367-9df2-57a919a11eb3",
  "productndc": "70000-0357",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "075915",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6.5%",
        "product_no": "001",
        "approval_date": "Nov 21, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TIOCONAZOLE",
  "proprietary_name": "Leader Tioconazole 1",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA075915",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tioconazole",
  "start_marketing_date": "20180420",
  "active_numerator_strength": "6.5"
}

Related drugs

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