Astonea Ointment
NDC Package 77338-307-05

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

Astonea (white petrolatum) ointment is  for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed. This formulation utilizes a ointment delivery system. Marketed by Astonea Labs Private Limited, this product is identified by NDC 77338-307 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
77338-307-05
Package Description
425 g in 1 JAR
Product Code
77338-307
11-Digit Billing Format
77338030705
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Astonea Vitamin A And D
Non-Proprietary Name
White Petrolatum
Substance Name
Petrolatum
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
PETROLATUM 76 g/100g
Usage Information
 for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Regulatory & Marketing

Labeler Name
Astonea Labs Private Limited
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-23-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (77338-307). Click a package code to view its specific billing and regulatory data.

77338-307-02
5 g in 1 PACKET
77338-307-03
28.3 g in 1 TUBE
77338-307-04
113 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 77338-307-05 identifies a specific commercial package of 425 g in 1 jar of Astonea Vitamin A And D, a human over the counter drug labeled by Astonea Labs Private Limited. This ointment is formulated for topical use and contains petrolatum 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 Astonea Labs Private Limited on May 23, 2013. The current certification is valid through December 31, 2026.

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: 77338030705. 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)
77338-307-05
11-Digit CMS (5-4-2)
77338-0307-05

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