topcare miconazole 1

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTopco Associates LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3680019900
1 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE

Annotations

Orange Book

A079114

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-199_aae0dcb7-6128-4681-b2c0-12be5aff38a1",
  "productndc": "36800-199",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "079114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%,1.2GM",
        "product_no": "001",
        "approval_date": "Jun 2, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "topcare miconazole 1",
  "active_ingred_unit": null,
  "application_number": "ANDA079114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20100617",
  "active_numerator_strength": null
}

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