Silka Cream
NDC Package 50066-080-03

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

Package Information

Silka (terbinafine hydrochloride) cream is adults and children 12 years and olderuse the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applying.for athlete's foot wear well-fitting, ventilated shoes. This formulation utilizes a cream delivery system. Marketed by Genomma Lab Usa, Inc., this product is identified by NDC 50066-080 and is authorized under FDA application ANDA077511.

Identification & Billing

NDC Package Code
50066-080-03
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
50066-080
11-Digit Billing Format
50066008003
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Silka Antifungal
Non-Proprietary Name
Terbinafine Hydrochloride
Substance Name
Terbinafine Hydrochloride
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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)
TERBINAFINE HYDROCHLORIDE 1 g/100g
Pharmacologic Class
Usage Information
Adults and children 12 years and olderuse the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applying.for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.Wash hands after each use.Children under 12 years: ask a doctor.

Regulatory & Marketing

Labeler Name
Genomma Lab Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA077511
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-02-2007
Listing Expiration
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50066-080). Click a package code to view its specific billing and regulatory data.

50066-080-02
1 TUBE in 1 CARTON / 30 g in 1 TUBE
50066-080-05
1 TUBE in 1 CARTON / 15 g in 1 TUBE

* 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 50066-080-03 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Silka Antifungal, a human over the counter drug labeled by Genomma Lab Usa, Inc.. This cream is formulated for topical use and contains terbinafine hydrochloride 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 Genomma Lab Usa, Inc. on July 02, 2007. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50066008003. 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)
50066-080-03
11-Digit CMS (5-4-2)
50066-0080-03

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