Novalgina Pediatrico Cough And Cold
NDC Package 83057-0002-2

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.

Novalgina Pediatrico Cough And Cold is other Information:Each 1 mlsStore between 15 - 30 degrees Celsius (59 - 86 Fahrenheit). Marketed by Hbc Pharma Llc, this product is identified by NDC 83057-0002 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
83057-0002-2
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
83057-0002
11-Digit Billing Format
83057000202
RxNorm Crosswalk
  • RxCUI: 1487369 - dextromethorphan HBr 7.5 MG / guaiFENesin 88 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution
  • RxCUI: 1487369 - dextromethorphan hydrobromide 7.5 MG/ML / guaifenesin 88 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1487369 - dextromethorphan HBr 7.5 MG / guaifenesin 88 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Solution

Clinical Specifications

Proprietary Name
Novalgina Pediatrico Cough And Cold Pediatrico
Dosage Form
-
Usage Information
Other Information:Each 1 mlsStore between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).

Regulatory & Marketing

Labeler Name
Hbc Pharma Llc
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2023
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 83057-0002-2 identifies a specific commercial package of 1 bottle in 1 carton / 60 ml in 1 bottle of Novalgina Pediatrico Cough And Cold Pediatrico, labeled by Hbc Pharma Llc. 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 Hbc Pharma Llc on February 01, 2023. The current certification is valid through December 31, 2025.

How is this Hbc Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83057000202. 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)
83057-0002-2
11-Digit CMS (5-4-2)
83057-0002-02

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