Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
NDC Package 42858-320-16

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 discontinued by the firm.

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide is a . Marketed by Rhodes Pharmaceuticals L.p., this product is identified by NDC 42858-320 and is authorized under FDA application ANDA202955.

Identification & Billing

NDC Package Code
42858-320-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
42858-320
11-Digit Billing Format
42858032016

Clinical Specifications

Proprietary Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage Form
-

Regulatory & Marketing

Labeler Name
Rhodes Pharmaceuticals L.p.
FDA Application #
ANDA202955
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2022
End Marketing Date
04-17-2024
Listing Expiration
04-17-2024
Exclude Flag
D
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 (42858-320). Click a package code to view its specific billing and regulatory data.

42858-320-12
118 mL in 1 BOTTLE, PLASTIC

* 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 42858-320-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide, labeled by Rhodes Pharmaceuticals L.p.. 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 Rhodes Pharmaceuticals L.p. on October 12, 2022. The current certification is valid through April 17, 2024.

How is this Rhodes Pharmaceuticals L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42858032016. 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)
42858-320-16
11-Digit CMS (5-4-2)
42858-0320-16

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