luzu

Generic: luliconazole

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name luzu
Generic Name luliconazole
Labeler bausch health us, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

luliconazole 10 mg/g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 99207-850
Product ID 99207-850_f18334bd-5ed1-43b2-87ba-80b803b54387
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204153
Listing Expiration 2026-12-31
Marketing Start 2013-11-14

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 2c19 inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 99207850
Hyphenated Format 99207-850

Supplemental Identifiers

RxCUI
1482684 1482689
UNII
RE91AN4S8G
NUI
N0000175487 M0002083 N0000182140

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name luzu (source: ndc)
Generic Name luliconazole (source: ndc)
Application Number NDA204153 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE
  • 1 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

99207-850-02 12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE 99207-850-60 1 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBE

Ingredients (1)

luliconazole (10 mg/g)

Linked Drug Pages (1)

Luzu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f18334bd-5ed1-43b2-87ba-80b803b54387", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140"], "unii": ["RE91AN4S8G"], "rxcui": ["1482684", "1482689"], "spl_set_id": ["a7016010-ce43-4c09-8d21-aeb697ffed31"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "12 TUBE in 1 CARTON (99207-850-02)  / 2 g in 1 TUBE", "package_ndc": "99207-850-02", "marketing_start_date": "20131114"}, {"sample": false, "description": "1 TUBE in 1 CARTON (99207-850-60)  / 60 g in 1 TUBE", "package_ndc": "99207-850-60", "marketing_start_date": "20131114"}], "brand_name": "Luzu", "product_id": "99207-850_f18334bd-5ed1-43b2-87ba-80b803b54387", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "product_ndc": "99207-850", "generic_name": "LULICONAZOLE", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Luzu", "active_ingredients": [{"name": "LULICONAZOLE", "strength": "10 mg/g"}], "application_number": "NDA204153", "marketing_category": "NDA", "marketing_start_date": "20131114", "listing_expiration_date": "20261231"}