Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Syrup
NDC Package 42192-607-40

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

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide (brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide) syrups is brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. This formulation utilizes a syrup delivery system. Marketed by Acella Pharmaceuticals, Llc, this product is identified by NDC 42192-607 and is authorized under FDA application ANDA203375.

Identification & Billing

NDC Package Code
42192-607-40
Package Description
40 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05)
Product Code
42192-607
11-Digit Billing Format
42192060740

Clinical Specifications

Proprietary Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Non-Proprietary Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Substance Name
Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Regulatory & Marketing

Labeler Name
Acella Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203375
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2016
Listing Expiration
12-31-2027
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 (42192-607). Click a package code to view its specific billing and regulatory data.

42192-607-04
118 mL in 1 BOTTLE, PLASTIC
42192-607-16
473 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 42192-607-40 identifies a specific commercial package of 40 cup, unit-dose in 1 case / 5 ml in 1 cup, unit-dose (42192-607-05) of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, a human prescription drug labeled by Acella Pharmaceuticals, Llc. This syrup is formulated for oral use and contains brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride 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 Acella Pharmaceuticals, Llc on September 21, 2016. The current certification is valid through December 31, 2027.

How is this Acella Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42192060740. 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)
42192-607-40
11-Digit CMS (5-4-2)
42192-0607-40

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