Nizoral

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerKramer Laboratories

CountryUS (United States)

ATC codeD01AC08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5550523265
400 mL in 1 CARTON (55505-232-65)

Annotations

UNII (FDA Substance ID)

R9400W927I

KETOCONAZOLE

RxCUI 6135

Orange Book

N020310

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R9400W927I",
    "rxcui": "6135",
    "inchikey": "XMAYWYJOQHXEEK-ZEQKJWHPSA-N;XMAYWYJOQHXEEK-OZXSUGGESA-N",
    "display_name": "KETOCONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "fee6763b-9762-4d91-a44a-b5a2203a1a45": {
      "match": "brand_token",
      "title": "NIZORAL PET (CHLORHEXIDINE GLUCONATE, KETOCONAZOLE) SHAMPOO [KRAMER LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "55505-232_adf1b4c5-24ad-4b4e-8ad6-f28d77d244ea",
  "productndc": "55505-232",
  "dosage_form": "SHAMPOO",
  "orange_book": {
    "appl_no": "020310",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Oct 10, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "Nizoral",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA020310",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ketoconazole",
  "start_marketing_date": "20251001",
  "active_numerator_strength": "1"
}

Related drugs

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