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  5. NDC Package Code: 83521-111-16 Dexbrompheniramine-dm-phenylephrine 2-15-7.5

NDC Package 83521-111-16 Dexbrompheniramine-dm-phenylephrine 2-15-7.5

Dexbrompheniramine Maleate,Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride - 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:
83521-111-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
83521-111
Proprietary Name:
Dexbrompheniramine-dm-phenylephrine 2-15-7.5
Non-Proprietary Name:
Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride
Substance Name:
Dexbrompheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
Do not exceed recommended dosage.  Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in a 24 hours Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor.
11-Digit NDC Billing Format:
83521011116
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1812101 - dexbrompheniramine maleate 2 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 7.5 MG in 5 mL Oral Solution
  • RxCUI: 1812101 - dexbrompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral Solution
  • RxCUI: 1812101 - dexbrompheniramine maleate 2 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 7.5 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Addgen Pharmaceuticals, Inc.
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXBROMPHENIRAMINE MALEATE 2 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 7.5 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:
    07-01-2023
    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 83521-111-16?

    The NDC Packaged Code 83521-111-16 is assigned to a package of 473 ml in 1 bottle of Dexbrompheniramine-dm-phenylephrine 2-15-7.5, a human over the counter drug labeled by Addgen Pharmaceuticals, Inc.. The product's dosage form is liquid and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package.

    Is NDC 83521-111 included in the NDC Directory?

    Yes, Dexbrompheniramine-dm-phenylephrine 2-15-7.5 with product code 83521-111 is active and included in the NDC Directory. The product was first marketed by Addgen Pharmaceuticals, Inc. on July 01, 2023 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 83521-111-16?

    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 473.

    What is the 11-digit format for NDC 83521-111-16?

    The 11-digit format is 83521011116. 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
    5-3-283521-111-165-4-283521-0111-16