NDC 40076-051

EXTINA

Ketoconazole

EXTINA is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Prestium Pharma, Inc.. The primary component is Ketoconazole.

• Product ID: 40076-051_1428eeb0-a875-4b64-bd8e-b24eba0189d5
• NDC: 40076-051
• Product Type: Human Prescription Drug
• Proprietary Name: EXTINA
• Generic Name: Ketoconazole
• Dosage Form: Aerosol, Foam
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-01-10
• Marketing End Date: 2019-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA021738
• Labeler Name: Prestium Pharma, 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

Packaging

NDC 40076-051-50

50 g in 1 CAN (40076-051-50)

• Marketing Start Date: 2014-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 40076-051-50 [40076005150]

EXTINA AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA021738
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-01-10
• Marketing End Date: 2019-05-31

NDC 40076-051-00 [40076005100]

EXTINA AEROSOL, FOAM

• Marketing Category: NDA
• Application Number: NDA021738
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-01-10
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
KETOCONAZOLE	20 mg/g

OpenFDA Data

• SPL SET ID: ceaee038-9681-45ab-b974-f32b72443022
• Manufacturer:
  • Prestium Pharma, Inc.
• UNII:
  • R9400W927I
• RxNorm Concept Unique ID - RxCUI:
  • 729768
  • 728550

Pharmacological Class

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

Medicade Reported Pricing

40076005150 EXTINA 2% FOAM

Pricing Unit: GM | Drug Type:

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

NDC	Brand Name	Generic Name
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
43538-530	Ketodan	ketoconazole
43538-531	Ketodan	ketoconazole
16110-080	Xolegel	ketoconazole