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United States · US · US:41520-426_765f1ed8-68e3-4902-b0db-4959632dcdd6

CareOne Tioconazole 1

Orange BookUNIISPLATC G01AF08

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeG01AF08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4152042654
    1 POUCH in 1 CARTON (41520-426-54) / 1 APPLICATOR in 1 POUCH / 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": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-426_765f1ed8-68e3-4902-b0db-4959632dcdd6",
  "productndc": "41520-426",
  "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": "CareOne Tioconazole 1",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA075915",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tioconazole",
  "start_marketing_date": "20080107",
  "active_numerator_strength": "6.5"
}

Related drugs

Other records sharing ATC code G01AF08.

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