Astonea Chest Rub
NDC Package 77338-321-21

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.

Astonea Chest Rub is see important warnings under " When using this product" adults and children 2 years and overrub a thick layer on throat & chest &cover with a warm, dry cloth if desiredkeep clothing loose about throat and chest to help vapors reach the nose and mouthuse up to three times daily or as directed by doctorfor muscle/joint minor aches and pains apply to affected area not more than 3 to 4 times dailychildren under 2 years: do not use. Marketed by Astonea Labs Private Limited, this product is identified by NDC 77338-321 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
77338-321-21
Package Description
113 g in 1 JAR
Product Code
77338-321
11-Digit Billing Format
77338032121
RxNorm Crosswalk
  • RxCUI: 2003749 - camphor 4.7 % / eucalyptus oil 1.2 % / menthol 1.25 % Topical Ointment
  • RxCUI: 2003749 - camphor 0.047 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.0125 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Astonea Chest Rub
Dosage Form
-
Usage Information
See important warnings under " When using this product" adults and children 2 years and overrub a thick layer on throat & chest &cover with a warm, dry cloth if desiredkeep clothing loose about throat and chest to help vapors reach the nose and mouthuse up to three times daily or as directed by doctorfor muscle/joint minor aches and pains apply to affected area not more than 3 to 4 times dailychildren under 2 years: do not use

Regulatory & Marketing

Labeler Name
Astonea Labs Private Limited
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-05-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 77338-321-21 identifies a specific commercial package of 113 g in 1 jar of Astonea Chest Rub, 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 April 05, 2019. 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: 77338032121. 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)
77338-321-21
11-Digit CMS (5-4-2)
77338-0321-21

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