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  5. NDC Package Code: 27808-057-01 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

NDC Package 27808-057-01 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

Solution 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:
27808-057-01
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
27808-057
Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Non-Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Substance Name:
Dextromethorphan Hydrobromide; Promethazine Hydrochloride
Usage Information:
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
11-Digit NDC Billing Format:
27808005701
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: 991528 - promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution
  • RxCUI: 991528 - dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 991528 - dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Tris Pharma Inc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL
  • PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
    • Pharmacologic Class(es):
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
  • 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)
    • Sample Package:
    No
    FDA Application Number:
    ANDA091687
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-31-2014
    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 27808-057-01?

    The NDC Packaged Code 27808-057-01 is assigned to a package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride And Dextromethorphan Hydrobromide, a human prescription drug labeled by Tris Pharma Inc. The product's dosage form is solution and is administered via oral form.

    Is NDC 27808-057 included in the NDC Directory?

    Yes, Promethazine Hydrochloride And Dextromethorphan Hydrobromide with product code 27808-057 is active and included in the NDC Directory. The product was first marketed by Tris Pharma Inc on January 31, 2014 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 27808-057-01?

    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 27808-057-01?

    The 11-digit format is 27808005701. 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
    5-3-227808-057-015-4-227808-0057-01