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United States · US · US:0168-0358_413f9391-fa2d-4449-b25d-fd11376f231e

Oxiconazole Nitrate

Orange BookUNIISPLATC G01AF17

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG01AF17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0168035830
    30 g in 1 TUBE (0168-0358-30)
  • ndc11
    0168035860
    60 g in 1 TUBE (0168-0358-60)
  • ndc11
    0168035890
    90 g in 1 TUBE (0168-0358-90)

Annotations

UNII (FDA Substance ID)
RQ8UL4C17S
OXICONAZOLE NITRATE
RxCUI 56226
Orange Book
N019828
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "RQ8UL4C17S",
    "rxcui": "56226",
    "inchikey": "WVNOAGNOIPTWPT-NDUABGMUSA-N",
    "display_name": "OXICONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "aa368d2b-a5d2-49dd-86e1-5693b68b46f4": {
      "match": "brand_token",
      "title": "OXICONAZOLE NITRATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS, LLC]",
      "spl_version": "5",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0168-0358_413f9391-fa2d-4449-b25d-fd11376f231e",
  "productndc": "0168-0358",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "019828",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXICONAZOLE NITRATE",
  "proprietary_name": "Oxiconazole Nitrate",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA019828",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Oxiconazole Nitrate",
  "start_marketing_date": "20160309",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G01AF17.

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