NDC 68682-850

LULICONAZOLE

Luliconazole

LULICONAZOLE is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Oceanside Pharmaceuticals. The primary component is Luliconazole.

• Product ID: 68682-850_0648b506-1c15-416b-9b4f-ecbb5b63188c
• NDC: 68682-850
• Product Type: Human Prescription Drug
• Proprietary Name: LULICONAZOLE
• Generic Name: Luliconazole
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-06-15
• Marketing Category: NDA / NDA
• Application Number: NDA204153
• Labeler Name: Oceanside Pharmaceuticals
• 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: 2019-12-31

Packaging

NDC 68682-850-60

1 TUBE in 1 CARTON (68682-850-60) > 60 g in 1 TUBE

• Marketing Start Date: 2018-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68682-850-60 [68682085060]

LULICONAZOLE CREAM

• Marketing Category: NDA
• Application Number: NDA204153
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-06-15

Drug Details

Active Ingredients

Ingredient	Strength
LULICONAZOLE	10 mg/g

OpenFDA Data

• SPL SET ID: 7ccda3ba-9c98-468d-83c6-7f0cc7c88c33
• Manufacturer:
  • Oceanside Pharmaceuticals
• UNII:
  • RE91AN4S8G
• RxNorm Concept Unique ID - RxCUI:
  • 1482684

Pharmacological Class

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

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

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