Australian Gold
NDC Package 13630-0121-4

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 inactivated by the FDA.

Australian Gold is shake well before useapply liberally 15 minutes before sun exposure and rub into skinhold container 4 to 6 inches from the skin to applydo not spray directly into face. Marketed by Prime Packaging Inc., this product is identified by NDC 13630-0121 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
13630-0121-4
Package Description
177 mL in 1 CAN
Product Code
13630-0121
11-Digit Billing Format
13630012104

Clinical Specifications

Proprietary Name
Australian Gold Justice Spf 50 Glitter Sunscreen
Dosage Form
-
Usage Information
Shake well before useapply liberally 15 minutes before sun exposure and rub into skinhold container 4 to 6 inches from the skin to applydo not spray directly into face. Spray on hands then apply to facedo not apply in windy conditionsuse in a well-ventilated areareapply:after 80 minutes of swimming and sweatingimmediately after towel dryingat least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a. m. - 2 p. m.wear long-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Prime Packaging Inc.
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-28-2017
Listing Expiration
12-31-2022
Exclude Flag
I
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 13630-0121-4 identifies a specific commercial package of 177 ml in 1 can of Australian Gold Justice Spf 50 Glitter Sunscreen, labeled by Prime Packaging 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 Prime Packaging Inc. on February 28, 2017. The current certification is valid through December 31, 2022.

How is this Prime Packaging Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13630012104. 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)
13630-0121-4
11-Digit CMS (5-4-2)
13630-0121-04

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