Silka Antifungal
NDC Package 50066-083-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Silka Antifungal is a medication not effective on the scalp or nails. Marketed by Genomma Lab Usa, this product is identified by NDC 50066-083 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
50066-083-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 13 mL in 1 BOTTLE, GLASS
Product Code
50066-083
11-Digit Billing Format
50066008301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Silka Antifungal
Dosage Form
-
Usage Information
This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorSupervise children in the use of this productFor athlete's foot: Pay special attention to spaces between the toes; wear well-ļ¬tting, ventilated shoes and change shoes and socks at least once dailyTo prevent athlete's foot, apply once or twice daily (morning and/or night)Apply to skin around the nail and cuticle.

Regulatory & Marketing

Labeler Name
Genomma Lab Usa
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-22-2022
Listing Expiration
12-31-2024
Exclude Flag
I
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 50066-083-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 13 ml in 1 bottle, glass of Silka Antifungal, labeled by Genomma Lab Usa. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Genomma Lab Usa on March 22, 2022. The current certification is valid through December 31, 2024.

How is this Genomma Lab Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50066008301. 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 (5-3-2)
50066-083-01
11-Digit CMS (5-4-2)
50066-0083-01

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