Miconazole 1 Combination Pack

Orange BookSPL

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

Identification

ManufacturerCVS PHARMACY, INC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5131600501
1 KIT in 1 PACKAGE, COMBINATION (51316-005-01) * 9 g in 1 TUBE (51316-091-01) * 1 SUPPOSITORY in 1 POUCH (51316-090-01)

Annotations

Orange Book

N020670

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "2f19d76f-1348-483e-8720-612d30928bb5": {
      "match": "brand_token",
      "title": "MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [SAFEWAY]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "51316-005_ceb2e359-e195-4a2c-82ea-9dd13cebcbeb",
  "productndc": "51316-005",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020670",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%,200MG",
        "product_no": "002",
        "approval_date": "Apr 16, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Miconazole 1 Combination Pack",
  "active_ingred_unit": null,
  "application_number": "NDA020670",
  "marketing_category": "NDA",
  "nonproprietary_name": "Miconazole Nitrate",
  "start_marketing_date": "20220130",
  "active_numerator_strength": null
}

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