NDC 67877-558 Brompheniramine, Pseudoephedrine, Dextromethorphan

Syrup Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
67877-558
Proprietary Name:
Brompheniramine, Pseudoephedrine, Dextromethorphan
Non-Proprietary Name: [1]
Brompheniramine, Pseudoephedrine, Dextromethorphan
Substance Name: [2]
Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Ascend Laboratories, Llc
    Labeler Code:
    67877
    FDA Application Number: [6]
    ANDA210647
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-16-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - LIGHT PINK)
    Flavor(s):
    BUTTERSCOTCH (C73372 - BUTTERSCOTCH)

    Product Packages

    NDC Code 67877-558-16

    Package Description: 473 mL in 1 BOTTLE

    NDC Code 67877-558-17

    Package Description: 118 mL in 1 BOTTLE

    Product Details

    What is NDC 67877-558?

    The NDC code 67877-558 is assigned by the FDA to the product Brompheniramine, Pseudoephedrine, Dextromethorphan which is a human prescription drug product labeled by Ascend Laboratories, Llc. The product's dosage form is syrup and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 67877-558-16 473 ml in 1 bottle , 67877-558-17 118 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Brompheniramine, Pseudoephedrine, Dextromethorphan?

    For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

    What are Brompheniramine, Pseudoephedrine, Dextromethorphan Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • BROMPHENIRAMINE MALEATE 2 mg/5mL - Histamine H1 antagonist used in treatment of allergies, rhinitis, and urticaria.
    • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    • PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

    Which are Brompheniramine, Pseudoephedrine, Dextromethorphan UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Brompheniramine, Pseudoephedrine, Dextromethorphan Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Brompheniramine, Pseudoephedrine, Dextromethorphan?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1357010 - brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution
    • RxCUI: 1357010 - brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
    • RxCUI: 1357010 - brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution

    Which are the Pharmacologic Classes for Brompheniramine, Pseudoephedrine, Dextromethorphan?

    * Please review the disclaimer below.

    Patient Education

    Brompheniramine


    Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    Dextromethorphan


    Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
    [Learn More]


    Pseudoephedrine


    Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".