Astonea
NDC Package 77338-802-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Astonea is ■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged. Marketed by Astonea Labs Private Limited, this product is identified by NDC 77338-802 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
77338-802-04
Package Description
452 g in 1 JAR
Product Code
77338-802
11-Digit Billing Format
77338080204
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Astonea Perishield
Dosage Form
-
Usage Information
■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Regulatory & Marketing

Labeler Name
Astonea Labs Private Limited
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-09-2022
Listing Expiration
12-31-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (77338-802). Click a package code to view its specific billing and regulatory data.

77338-802-00
100 g in 1 TUBE

* 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 77338-802-04 identifies a specific commercial package of 452 g in 1 jar of Astonea Perishield, labeled by Astonea Labs Private Limited. 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 Astonea Labs Private Limited on August 09, 2022. The current certification is valid through December 31, 2025.

How is this Astonea Labs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77338080204. 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)
77338-802-04
11-Digit CMS (5-4-2)
77338-0802-04

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