Amorepacific Lotion
NDC Package 43419-511-21

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

Package Information

Amorepacific (octinoxate, titanium dioxide, and zinc oxide) lotions is use in the morning and reapply regularly throughout the day if desired. This formulation utilizes a lotion delivery system. Marketed by Amorepacific Corporation, this product is identified by NDC 43419-511 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
43419-511-21
Package Description
2 CONTAINER in 1 CARTON / 15 g in 1 CONTAINER
Product Code
43419-511
11-Digit Billing Format
43419051121

Clinical Specifications

Proprietary Name
Amorepacific Color Control Cushion Compact No.104
Non-Proprietary Name
Octinoxate, Titanium Dioxide, And Zinc Oxide
Substance Name
Octinoxate; Titanium Dioxide; Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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)
Usage Information
Use in the morning and reapply regularly throughout the day if desired. Children under 6 months of age : ask a doctor

Regulatory & Marketing

Labeler Name
Amorepacific Corporation
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-05-2012
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 43419-511-21 identifies a specific commercial package of 2 container in 1 carton / 15 g in 1 container of Amorepacific Color Control Cushion Compact No.104, a human over the counter drug labeled by Amorepacific Corporation. This lotion is formulated for topical use and contains octinoxate; titanium dioxide; zinc oxide 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 Amorepacific Corporation on December 05, 2012. The current certification is valid through December 31, 2026.

How is this Amorepacific Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43419051121. 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)
43419-511-21
11-Digit CMS (5-4-2)
43419-0511-21

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