Bromfed Dm
NDC Package 68025-002-16

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.

Bromfed Dm is this combination medication is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Marketed by Vertical Pharmaceuticals, Llc, this product is identified by NDC 68025-002 and is authorized under FDA application ANDA203375.

Identification & Billing

NDC Package Code
68025-002-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
68025-002
11-Digit Billing Format
68025000216

Clinical Specifications

Proprietary Name
Bromfed Dm
Dosage Form
-
Usage Information
This combination medication is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Dextromethorphan is a cough suppressant that affects a certain part of the brain (cough center), reducing the urge to cough. Decongestants help relieve stuffy nose symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Regulatory & Marketing

Labeler Name
Vertical Pharmaceuticals, Llc
FDA Application #
ANDA203375
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2022
End Marketing Date
12-31-2022
Listing Expiration
12-31-2022
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 (68025-002). Click a package code to view its specific billing and regulatory data.

68025-002-04
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 68025-002-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Bromfed Dm, labeled by Vertical Pharmaceuticals, 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 Vertical Pharmaceuticals, Llc on December 31, 2022. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

This combination medication is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Dextromethorphan is a cough suppressant that affects a certain part of the brain (cough center), reducing the urge to cough. Decongestants help relieve stuffy nose symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68025000216. 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)
68025-002-16
11-Digit CMS (5-4-2)
68025-0002-16

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