55505-196 : Nizoral 10 mg/ml Topical Shampoo

Labeler: Kramer Laboratories
Product Type: Human OTC Drug
Drug Name:  Nizoral
Dosage Form: Topical Shampoo
Application #: NDA020310
Rev. Date: 

NDC Package Codes:

  • 55505-196-33: 1 BOTTLE IN 1 CARTON (55505‑196‑33) > 125 ML IN 1 BOTTLE
  • 55505-196-40: 1 BOTTLE IN 1 CARTON (55505‑196‑40) > 200 ML IN 1 BOTTLE
  • 55505-196-64: 1 BOTTLE IN 1 CARTON (55505‑196‑64) > 325 ML IN 1 BOTTLE
  • 55505-196-65: 1 CARTON IN 1 CARTON (55505‑196‑65) > 400 ML IN 1 CARTON

Active Ingredients:

  • Ketoconazole

Dosage Strength:

  • 10 mg/mL

Pharmaceutical Classes:

  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 3A5 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 55505-191 Nizoral 10 mg/ml Topical Shampoo by Kramer Laboratories
  • 55505-192 Nizoral 10 mg/ml Topical Shampoo by Kramer Laboratories
  • 50458-220 Nizoral 200 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-680 Nizoral 20 mg/ml Topical Shampoo by Janssen Pharmaceuticals, Inc.
  • 54569-3394 Nizoral 20 mg/ml Topical Shampoo by A-s Medication Solutions LLC


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