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 · 9

ndc11
5550519633
1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE
ndc11
5550519640
1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE
ndc11
5550519647
4 mL in 1 PACKET (55505-196-47)
ndc11
5550519657
2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE
ndc11
5550519665
1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON
ndc11
5550519668
3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE
ndc11
5550519672
2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE
ndc11
5550519684
2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE
ndc11
5550519685
1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE

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": "55505-196_443a0d0c-3098-4c35-97f8-8d01a7b3c83a",
  "productndc": "55505-196",
  "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": "mg/mL",
  "application_number": "NDA020310",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ketoconazole",
  "start_marketing_date": "20220616",
  "active_numerator_strength": "10"
}

Related drugs

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