Antiseptic Skin Cleanser
NDC Package 0116-0237-01

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 discontinued by the firm.

Antiseptic Skin Cleanser is use with care in premature infants or infants under 2 months of age. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-0237 and is authorized under FDA application NDA019125.

Identification & Billing

NDC Package Code
0116-0237-01
Package Description
237 mL in 1 BOTTLE, PLASTIC
Product Code
0116-0237
11-Digit Billing Format
00116023701

Clinical Specifications

Proprietary Name
Antiseptic Skin Cleanser
Dosage Form
-
Usage Information
Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.Surgical hand scrub:wet hands and forearms under running waterscrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spacesa separate nail cleaner may be usedrinse thoroughlywash for an additional 3 minutes with 5 mL of product and rinse under running waterdry thoroughlyHealthcare personnel handwash:wet hands with waterdispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 secondsrinse and dry thoroughlyPatient preoperative skin preparation:apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towelrepeat procedure for an additional 2 minutes and dry with a sterile towelSkin wound and general skin cleansing:thoroughly rinse the area to be cleaned with waterapply the minimum amount of product necessary to cover the skin or wound area and wash gentlyrinse again thoroughly

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
FDA Application #
NDA019125
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-20-2014
End Marketing Date
06-30-2025
Listing Expiration
06-30-2025
Exclude Flag
D
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 0116-0237-01 identifies a specific commercial package of 237 ml in 1 bottle, plastic of Antiseptic Skin Cleanser, labeled by Xttrium Laboratories, Inc.. 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 Xttrium Laboratories, Inc. on February 20, 2014. The current certification is valid through June 30, 2025.

How is this Xttrium Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116023701. 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)
0116-0237-01
11-Digit CMS (5-4-2)
00116-0237-01

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