NDC 72934-2112

HYDROCORTISONE 2.5% / KETOCONAZOLE 2%

Hydrocortisone 2.5% / Ketoconazole 2%

HYDROCORTISONE 2.5% / KETOCONAZOLE 2% is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Hydrocortisone; Ketoconazole.

• Product ID: 72934-2112_89026ad5-ed04-5058-e053-2a95a90ad2b0
• NDC: 72934-2112
• Product Type: Human Prescription Drug
• Proprietary Name: HYDROCORTISONE 2.5% / KETOCONAZOLE 2%
• Generic Name: Hydrocortisone 2.5% / Ketoconazole 2%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-17
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sincerus Florida, LLC
• Substance Name: HYDROCORTISONE; KETOCONAZOLE
• Active Ingredient Strength: 3 g/100g; g/100g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],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 72934-2112-2

30 g in 1 BOTTLE, PUMP (72934-2112-2)

• Marketing Start Date: 2019-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72934-2112-2 [72934211202]

HYDROCORTISONE 2.5% / KETOCONAZOLE 2% CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE	2.5 g/100g

OpenFDA Data

• SPL SET ID: 89026ad5-ed03-5058-e053-2a95a90ad2b0
• Manufacturer:
  • Sincerus Florida, LLC
• UNII:
  • R9400W927I
  • WI4X0X7BPJ

Pharmacological Class

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