Biospec
NDC Package 45737-264-16

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.

Biospec is Usestemporarily relieves cough due to minor throat and bronchial irritation as may occur with coldhelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive. Marketed by Advanced Generic Corporation, this product is identified by NDC 45737-264 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
45737-264-16
Package Description
473 mL in 1 BOTTLE
Product Code
45737-264
11-Digit Billing Format
45737026416
RxNorm Crosswalk
  • RxCUI: 1441364 - dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral Solution
  • RxCUI: 1441364 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral Solution
  • RxCUI: 1441364 - dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Biospec Dmx
Dosage Form
-
Usage Information
Usestemporarily relieves cough due to minor throat and bronchial irritation as may occur with coldhelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Regulatory & Marketing

Labeler Name
Advanced Generic Corporation
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2015
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 45737-264-16 identifies a specific commercial package of 473 ml in 1 bottle of Biospec Dmx, labeled by Advanced Generic Corporation. 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 Advanced Generic Corporation on March 01, 2015. The current certification is valid through December 31, 2025.

How is this Advanced Generic Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45737026416. 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)
45737-264-16
11-Digit CMS (5-4-2)
45737-0264-16

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