NDC 43538-530

Ketodan

Ketoconazole

Ketodan is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals, Inc.. The primary component is Ketoconazole.

• Product ID: 43538-530_0ea6f081-8714-4c58-a811-1a1c091a4dcf
• NDC: 43538-530
• Product Type: Human Prescription Drug
• Proprietary Name: Ketodan
• Generic Name: Ketoconazole
• Dosage Form: Aerosol, Foam
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-06-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091550
• Labeler Name: Medimetriks Pharmaceuticals, Inc.
• Substance Name: KETOCONAZOLE
• Active Ingredient Strength: 20 mg/g
• 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: 2023-12-31

Packaging

NDC 43538-530-10

1 CAN in 1 CARTON (43538-530-10) > 100 g in 1 CAN

• Marketing Start Date: 2012-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43538-530-10 [43538053010]

Ketodan AEROSOL, FOAM

• Marketing Category: ANDA
• Application Number: ANDA091550
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-06-15

Drug Details

Active Ingredients

Ingredient	Strength
KETOCONAZOLE	20 mg/g

OpenFDA Data

• SPL SET ID: 62f19bd8-926e-4e6b-9097-d81b894b95cc
• Manufacturer:
  • Medimetriks Pharmaceuticals, Inc.
• UNII:
  • R9400W927I
• RxNorm Concept Unique ID - RxCUI:
  • 1300272
  • 728550

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]

Medicade Reported Pricing

43538053010 KETODAN 2% FOAM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Ketodan" or generic name "Ketoconazole"

NDC	Brand Name	Generic Name
43538-530	Ketodan	ketoconazole
43538-531	Ketodan	ketoconazole
0378-8136	EXTINA	ketoconazole
40076-051	EXTINA	ketoconazole
0093-0900	Ketoconazole	Ketoconazole
0093-3219	Ketoconazole	Ketoconazole
0168-0099	ketoconazole	ketoconazole
0378-0261	Ketoconazole	ketoconazole
0713-0671	Ketoconazole	Ketoconazole
10147-0750	KETOCONAZOLE	ketoconazole
16714-955	Ketoconazole	Ketoconazole
21695-554	Ketoconazole	Ketoconazole
21695-555	Ketoconazole	Ketoconazole
21695-556	Ketoconazole	Ketoconazole
21695-562	Ketoconazole	Ketoconazole
33261-739	Ketoconazole	Ketoconazole
35573-433	KETOCONAZOLE	ketoconazole
43063-036	Ketoconazole	ketoconazole
43063-882	Ketoconazole	Ketoconazole
45802-465	Ketoconazole	Ketoconazole
45802-532	ketoconazole	ketoconazole
50090-0719	ketoconazole	ketoconazole
50090-0720	ketoconazole	ketoconazole
50090-1220	Ketoconazole	Ketoconazole
16110-080	Xolegel	ketoconazole