Vusion Ointment
NDC Package 0378-9730-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vusion (miconazole nitrate, zinc oxide, white petrolatum) ointment is a medication used in children to treat diaper rash with a yeast infection, along with proper cleaning of the diaper area and frequent diaper changes. This formulation utilizes a ointment delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-9730 and is authorized under FDA application NDA021026.

Identification & Billing

NDC Package Code
0378-9730-50
Package Description
1 TUBE in 1 CARTON / 50 g in 1 TUBE
Product Code
0378-9730
11-Digit Billing Format
00378973050
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk
  • RxCUI: 831391 - miconazole nitrate 0.25 % / zinc oxide 15 % / petrolatum 81.4 % Topical Ointment
  • RxCUI: 831391 - miconazole nitrate 0.0025 MG/MG / petrolatum 0.814 MG/MG / zinc oxide 0.15 MG/MG Topical Ointment
  • RxCUI: 831391 - Miconazole Nitrate 0.0025 MG/MG / Petrolatum 0.814 MG/MG / ZNO 0.15 MG/MG Topical Ointment
  • RxCUI: 831391 - miconazole nitrate 0.25 % / petrolatum, white 81.35 % / zinc oxide 15 % Topical Ointment
  • RxCUI: 831393 - Vusion 0.25 % / 15 % / 81.35 % Topical Ointment

Clinical Specifications

Proprietary Name
Vusion
Non-Proprietary Name
Miconazole Nitrate, Zinc Oxide, White Petrolatum
Substance Name
Miconazole Nitrate; Petrolatum; Zinc Oxide
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is used in children to treat diaper rash with a yeast infection, along with proper cleaning of the diaper area and frequent diaper changes. Miconazole is an azole antifungal that works by preventing the growth of fungus. Zinc oxide and petrolatum work by forming a barrier on the skin to protect it from moisture and irritation. This product should not be used long-term or to prevent diaper rash. Unnecessary use or misuse of this product can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021026
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-06-2020
End Marketing Date
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-9730-50 identifies a specific commercial package of 1 tube in 1 carton / 50 g in 1 tube of Vusion, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package. This ointment is formulated for topical use and contains miconazole nitrate; petrolatum; zinc oxide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mylan Pharmaceuticals Inc. on February 06, 2020.

What are the primary indications for this medication?

This product is used in children to treat diaper rash with a yeast infection, along with proper cleaning of the diaper area and frequent diaper changes. Miconazole is an azole antifungal that works by preventing the growth of fungus. Zinc oxide and petrolatum work by forming a barrier on the skin to protect it from moisture and irritation. This product should not be used long-term or to prevent diaper rash. Unnecessary use or misuse of this product can lead to its decreased effectiveness.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378973050. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0378-9730-50
11-Digit CMS (5-4-2)
00378-9730-50

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.