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United States · US · US:62559-285_c38f8751-f5da-4333-b12a-2ca8c1816a32

Oxistat

Orange BookUNIISPLATC G01AF17

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG01AF17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6255928506
    6 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE
  • ndc11
    6255928530
    1 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE
  • ndc11
    6255928560
    1 BOTTLE in 1 CARTON (62559-285-60) / 60 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
RQ8UL4C17S
OXICONAZOLE NITRATE
RxCUI 56226
Orange Book
N020209
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": {
    "64ef2286-0f56-4a8a-b07b-4a597f078ae0": {
      "match": "brand_token",
      "title": "OXISTAT (OXICONAZOLE NITRATE) LOTION [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-07-28"
    }
  },
  "productid": "62559-285_c38f8751-f5da-4333-b12a-2ca8c1816a32",
  "productndc": "62559-285",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "020209",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Sep 30, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXICONAZOLE NITRATE",
  "proprietary_name": "Oxistat",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020209",
  "marketing_category": "NDA",
  "nonproprietary_name": "oxiconazole nitrate",
  "start_marketing_date": "20220912",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G01AF17.

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