Lamisil At Cream
NDC Package 84485-3607-1

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

Package Information

Lamisil At Cream (terbinafine hydrochloride) cream is adults and children 12 years and over:use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingapply once a day (morning or night) for 1 week or as directed by a doctorwash hands after each usechildren under 12 years: ask a doctor. This formulation utilizes a cream delivery system. Marketed by Karo Healthcare Inc., this product is identified by NDC 84485-3607 and is authorized under FDA application NDA020980.

Identification & Billing

NDC Package Code
84485-3607-1
Package Description
1 TUBE in 1 CARTON / 12 g in 1 TUBE
Product Code
84485-3607
11-Digit Billing Format
84485360701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamisil At Cream
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 over:use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingapply once a day (morning or night) for 1 week or as directed by a doctorwash hands after each usechildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Karo Healthcare Inc.
Product Type
Human Otc Drug
FDA Application #
NDA020980
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-20-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84485-3607-1 identifies a specific commercial package of 1 tube in 1 carton / 12 g in 1 tube of Lamisil At Cream, a human over the counter drug labeled by Karo Healthcare 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 Karo Healthcare Inc. on January 20, 2025. The current certification is valid through December 31, 2026.

How is this Karo Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84485360701. 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 (5-4-1)
84485-3607-1
11-Digit CMS (5-4-2)
84485-3607-01

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