NDC 99207-850

Luzu

Luliconazole

Luzu is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Luliconazole.

• Product ID: 99207-850_76ac026f-e6f1-4d1f-8144-9b5492e2d1bb
• NDC: 99207-850
• Product Type: Human Prescription Drug
• Proprietary Name: Luzu
• Generic Name: Luliconazole
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-11-14
• Marketing Category: NDA / NDA
• Application Number: NDA204153
• Labeler Name: Bausch Health US, LLC
• Substance Name: LULICONAZOLE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 99207-850-02

12 TUBE in 1 CARTON (99207-850-02) > 2 g in 1 TUBE

• Marketing Start Date: 2013-11-14
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 99207-850-02 [99207085002]

Luzu CREAM

• Marketing Category: NDA
• Application Number: NDA204153
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-14

NDC 99207-850-60 [99207085060]

Luzu CREAM

• Marketing Category: NDA
• Application Number: NDA204153
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2013-11-14

NDC 99207-850-30 [99207085030]

Luzu CREAM

• Marketing Category: NDA
• Application Number: NDA204153
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-14
• Marketing End Date: 2015-01-05

Drug Details

Active Ingredients

Ingredient	Strength
LULICONAZOLE	10 mg/g

OpenFDA Data

• SPL SET ID: a7016010-ce43-4c09-8d21-aeb697ffed31
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • RE91AN4S8G
• RxNorm Concept Unique ID - RxCUI:
  • 1482684
  • 1482689

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 2C19 Inhibitors [MoA]

Medicade Reported Pricing

99207085060 LUZU 1% CREAM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Luzu" or generic name "Luliconazole"

NDC	Brand Name	Generic Name
99207-850	Luzu	LULICONAZOLE
68682-850	LULICONAZOLE	LULICONAZOLE