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  5. NDC Package Code: 83057-0002-2 Novalgina Pediatrico Cough And Cold Pediatrico

NDC Package 83057-0002-2 Novalgina Pediatrico Cough And Cold Pediatrico

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:
83057-0002-2
Package Description:
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code:
83057-0002
Proprietary Name:
Novalgina Pediatrico Cough And Cold Pediatrico
Non-Proprietary Name:
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Other Information:Each 1 mlsStore between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
11-Digit NDC Billing Format:
83057000202
NDC to RxNorm Crosswalk:
  • RxCUI: 1487369 - dextromethorphan HBr 7.5 MG / guaiFENesin 88 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution
  • RxCUI: 1487369 - dextromethorphan hydrobromide 7.5 MG/ML / guaifenesin 88 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1487369 - dextromethorphan HBr 7.5 MG / guaifenesin 88 MG / phenylephrine HCl 2.5 MG per 1 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):
  • DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/mL
  • GUAIFENESIN 88 mg/mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/mL
    • 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:
    02-01-2023
    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 83057-0002-2?

    The NDC Packaged Code 83057-0002-2 is assigned to a package of 1 bottle in 1 carton / 60 ml in 1 bottle of Novalgina Pediatrico Cough And Cold Pediatrico, 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 83057-0002 included in the NDC Directory?

    Yes, Novalgina Pediatrico Cough And Cold Pediatrico with product code 83057-0002 is active and included in the NDC Directory. The product was first marketed by Hbc Pharma Llc on February 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 11-digit format for NDC 83057-0002-2?

    The 11-digit format is 83057000202. 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
    5-4-183057-0002-25-4-283057-0002-02