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United States · US · US:41520-825_dd6f9159-8c07-49f6-a043-99222a327cba

Careone miconazole 7

Orange BookUNIISPLATC G01AF04

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4152082529
    1 TUBE in 1 CARTON (41520-825-29) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A074760
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VW4H1CYW1K",
    "rxcui": "42790",
    "inchikey": "MCCACAIVAXEFAL-UHFFFAOYSA-N",
    "display_name": "MICONAZOLE NITRATE",
    "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": "41520-825_dd6f9159-8c07-49f6-a043-99222a327cba",
  "productndc": "41520-825",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "074760",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "May 15, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MICONAZOLE NITRATE",
  "proprietary_name": "Careone miconazole 7",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA074760",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20190529",
  "active_numerator_strength": "2"
}

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