NDC 72934-2132

KETOCONAZOLE 2% / NIACINAMIDE 4%

Ketoconazole 2% / Niacinamide 4%

KETOCONAZOLE 2% / NIACINAMIDE 4% is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida Llc. The primary component is Ketoconazole; Niacinamide.

• Product ID: 72934-2132_88c97b7c-b917-bd3a-e053-2995a90ab422
• NDC: 72934-2132
• Product Type: Human Prescription Drug
• Proprietary Name: KETOCONAZOLE 2% / NIACINAMIDE 4%
• Generic Name: Ketoconazole 2% / Niacinamide 4%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-13
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sincerus Florida LLC
• Substance Name: KETOCONAZOLE; NIACINAMIDE
• Active Ingredient Strength: 2 g/100g; g/100g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72934-2132-2

30 g in 1 BOTTLE, PUMP (72934-2132-2)

• Marketing Start Date: 2019-05-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72934-2132-2 [72934213202]

KETOCONAZOLE 2% / NIACINAMIDE 4% CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-13

Drug Details

Active Ingredients

Ingredient	Strength
KETOCONAZOLE	2 g/100g

OpenFDA Data

• SPL SET ID: 88c97b7c-b916-bd3a-e053-2995a90ab422
• Manufacturer:
  • Sincerus Florida LLC
• UNII:
  • 25X51I8RD4
  • R9400W927I

Pharmacological Class

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