Crotamiton Liquid
NDC Package 48581-310-55

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Crotamiton liquids is a medication used to treat scabies. This formulation utilizes a liquid delivery system. Marketed by Egis Pharmaceuticals Plc, this product is identified by NDC 48581-310.

Identification & Billing

NDC Package Code
48581-310-55
Package Description
23 kg in 1 DRUM
Product Code
48581-310
11-Digit Billing Format
48581031055

Clinical Specifications

Proprietary Name
Crotamiton
Non-Proprietary Name
Crotamiton
Substance Name
Crotamiton
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
CROTAMITON 1 kg/kg
Usage Information
This medication is used to treat scabies. Scabies is a skin infection caused by mites that burrow into the skin. Irritation from the mites leads to severe itching and small bumps/blisters filled with fluid/pus. Crotamiton works by killing the mites that cause scabies. It also helps relieve itching related to scabies and other skin conditions. Crotamiton belongs to two classes of drugs: scabicides and antipruritics.

Regulatory & Marketing

Labeler Name
Egis Pharmaceuticals Plc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-31-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 48581-310-55 identifies a specific commercial package of 23 kg in 1 drum of Crotamiton (UNFINISHED drug), a bulk ingredient labeled by Egis Pharmaceuticals Plc. This liquid is formulated for use and contains crotamiton 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 Egis Pharmaceuticals Plc on July 31, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat scabies. Scabies is a skin infection caused by mites that burrow into the skin. Irritation from the mites leads to severe itching and small bumps/blisters filled with fluid/pus. Crotamiton works by killing the mites that cause scabies. It also helps relieve itching related to scabies and other skin conditions. Crotamiton belongs to two classes of drugs: scabicides and antipruritics.

How is this Egis Pharmaceuticals Plc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48581031055. 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)
48581-310-55
11-Digit CMS (5-4-2)
48581-0310-55

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