NDC 16110-080

Xolegel

Ketoconazole

Xolegel is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Ketoconazole.

• Product ID: 16110-080_285472ff-4b8a-4977-94ad-0b5bd39835bf
• NDC: 16110-080
• Product Type: Human Prescription Drug
• Proprietary Name: Xolegel
• Generic Name: Ketoconazole
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2006-07-28
• Marketing Category: NDA / NDA
• Application Number: NDA021946
• Labeler Name: Almirall, LLC
• 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: 2020-12-31

Packaging

NDC 16110-080-45

1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE

• Marketing Start Date: 2006-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-080-02 [16110008002]

Xolegel GEL

• Marketing Category: NDA
• Application Number: NDA021946
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-07-28
• Marketing End Date: 2015-03-24

NDC 16110-080-45 [16110008045]

Xolegel GEL

• Marketing Category: NDA
• Application Number: NDA021946
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-07-28

Drug Details

Active Ingredients

Ingredient	Strength
KETOCONAZOLE	20 mg/g

OpenFDA Data

• SPL SET ID: 855e42bb-b57f-4772-bffa-d766ddcc46ce
• Manufacturer:
  • Aqua Pharmaceuticals
• UNII:
  • R9400W927I
• RxNorm Concept Unique ID - RxCUI:
  • 664961
  • 647253

Pharmacological Class

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

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

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