Latalia Alcohol Antiseptic 80% Sanitizing Liquid
NDC Package 80016-005-01

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

Package Information

Latalia Alcohol Antiseptic 80% Sanitizing (alcohol) liquids is place enough product on hands to cover all surfaces.Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing. This formulation utilizes a liquid delivery system. Marketed by International Consumer Products (pvt) Ltd, this product is identified by NDC 80016-005 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
80016-005-01
Package Description
55 mL in 1 BOTTLE
Product Code
80016-005
11-Digit Billing Format
80016000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Latalia Alcohol Antiseptic 80% Sanitizing
Non-Proprietary Name
Alcohol
Substance Name
Alcohol
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.
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)
ALCOHOL 80 mL/100mL
Usage Information
Place enough product on hands to cover all surfaces.Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
International Consumer Products (pvt) Ltd
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2023
Listing Expiration
12-31-2027
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 80016-005-01 identifies a specific commercial package of 55 ml in 1 bottle of Latalia Alcohol Antiseptic 80% Sanitizing, a human over the counter drug labeled by International Consumer Products (pvt) Ltd. This liquid is formulated for topical use and contains alcohol 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 International Consumer Products (pvt) Ltd on September 15, 2023. The current certification is valid through December 31, 2027.

How is this International Consumer Products (pvt) Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80016000501. 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)
80016-005-01
11-Digit CMS (5-4-2)
80016-0005-01

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