vusion

Generic: miconazole nitrate, zinc oxide, white petrolatum

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name vusion
Generic Name miconazole nitrate, zinc oxide, white petrolatum
Labeler mylan pharmaceuticals inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2.5 mg/g, petrolatum 813.5 mg/g, zinc oxide 150 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8222
Product ID 0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021026
Marketing Start 2018-11-06
Marketing End 2026-12-31

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788222
Hyphenated Format 0378-8222

Supplemental Identifiers

RxCUI
831391 831393
UNII
VW4H1CYW1K 4T6H12BN9U SOI2LOH54Z

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 vusion (source: ndc)
Generic Name miconazole nitrate, zinc oxide, white petrolatum (source: ndc)
Application Number NDA021026 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/g
  • 813.5 mg/g
  • 150 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBE
source: ndc

Packages (1)

0378-8222-50 1 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBE

Ingredients (3)

miconazole nitrate (2.5 mg/g) petrolatum (813.5 mg/g) zinc oxide (150 mg/g)

Linked Drug Pages (1)

VUSION ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0", "openfda": {"unii": ["VW4H1CYW1K", "4T6H12BN9U", "SOI2LOH54Z"], "rxcui": ["831391", "831393"], "spl_set_id": ["b026bc7d-3a18-41e8-88c4-1e063cd2f42c"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-8222-50)  / 50 g in 1 TUBE", "package_ndc": "0378-8222-50", "marketing_end_date": "20261231", "marketing_start_date": "20181106"}], "brand_name": "VUSION", "product_id": "0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0", "dosage_form": "OINTMENT", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0378-8222", "generic_name": "miconazole nitrate, zinc oxide, white petrolatum", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VUSION", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2.5 mg/g"}, {"name": "PETROLATUM", "strength": "813.5 mg/g"}, {"name": "ZINC OXIDE", "strength": "150 mg/g"}], "application_number": "NDA021026", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20261231", "marketing_start_date": "20181106"}