equate miconazole 1

Orange BookSPL

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

Identification

ManufacturerWal-Mart Stores Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4903519900
1 KIT in 1 CARTON (49035-199-00) * 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": {
    "2ac53cc7-000f-41fd-b799-4e6d6886fe62": {
      "match": "brand_token",
      "title": "EQUATE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "49035-199_9a579cfa-9516-480f-af93-47470131b2e2",
  "productndc": "49035-199",
  "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": "equate miconazole 1",
  "active_ingred_unit": null,
  "application_number": "ANDA079114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Miconazole nitrate",
  "start_marketing_date": "20100609",
  "active_numerator_strength": null
}

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