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  5. NDC Package Code: 83057-0001-6 Novalgina Children Cough And Cold

NDC Package 83057-0001-6 Novalgina Children Cough And Cold

Acetaminofen,Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hcl Liquid Oral - 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:
83057-0001-6
Package Description:
1 BOTTLE in 1 CARTON / 180 mL in 1 BOTTLE
Product Code:
83057-0001
Proprietary Name:
Novalgina Children Cough And Cold
Non-Proprietary Name:
Acetaminofen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Other Information:Each 10 mls contains: sodium 4 mgStore between 15 - 30 degrees Celsius (59 - 86 Fahrenheit). Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.
11-Digit NDC Billing Format:
83057000106
NDC to RxNorm Crosswalk:
  • RxCUI: 1790651 - acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution
  • RxCUI: 1790651 - acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1790651 - acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1790651 - acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1790651 - APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Hbc Pharma, Llc
    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):
  • ACETAMINOPHEN 250 mg/10mL
  • DEXTROMETHORPHAN HYDROBROMIDE 13.33 mg/10mL
  • GUAIFENESIN 200 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • 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:
    11-01-2022
    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 83057-0001-6?

    The NDC Packaged Code 83057-0001-6 is assigned to a package of 1 bottle in 1 carton / 180 ml in 1 bottle of Novalgina Children Cough And Cold, a human over the counter drug labeled by Hbc Pharma, Llc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 83057-0001 included in the NDC Directory?

    Yes, Novalgina Children Cough And Cold with product code 83057-0001 is active and included in the NDC Directory. The product was first marketed by Hbc Pharma, Llc on November 01, 2022 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 11-digit format for NDC 83057-0001-6?

    The 11-digit format is 83057000106. 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 5-4-1 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
    5-4-183057-0001-65-4-283057-0001-06