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  5. NDC Package Code: 52083-637-16 Presgen B

NDC Package 52083-637-16 Presgen B

Dextromethorphan Hydrobromide,Brompheniramine Maleate,Phenylephrine Hydrochloride Syrup - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
52083-637-16
Package Description:
480 mL in 1 BOTTLE
Product Code:
52083-637
Proprietary Name:
Presgen B
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Brompheniramine Maleate, Phenylephrine Hydrochloride
Substance Name:
Brompheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
:  relieves nasal congestion associated with sinusitis. relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. relieves sinus congestion and pressure ,helps decongest sinus openings and passages. restores free breathing. suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergie
11-Digit NDC Billing Format:
52083063716
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
480 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1148155 - brompheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1148155 - brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1148155 - brompheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Kramer Novis
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BROMPHENIRAMINE MALEATE 4 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    03-29-2011
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 52083-637-16?

    The NDC Packaged Code 52083-637-16 is assigned to a package of 480 ml in 1 bottle of Presgen B, a human over the counter drug labeled by Kramer Novis. The product's dosage form is syrup and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 480 billable units per package.

    Is NDC 52083-637 included in the NDC Directory?

    Yes, Presgen B with product code 52083-637 is active and included in the NDC Directory. The product was first marketed by Kramer Novis on March 29, 2011 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 52083-637-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 480.

    What is the 11-digit format for NDC 52083-637-16?

    The 11-digit format is 52083063716. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252083-637-165-4-252083-0637-16