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  5. NDC Package Code: 64679-604-16 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

NDC Package 64679-604-16 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

Syrup 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:
64679-604-16
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
64679-604
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 syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
11-Digit NDC Billing Format:
64679060416
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:
    Wockhardt Usa Llc.
    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):
  • 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:
    ANDA088864
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-04-1985
    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 64679-604-16?

    The NDC Packaged Code 64679-604-16 is assigned to a package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride And Dextromethorphan Hydrobromide, a human prescription drug labeled by Wockhardt Usa Llc.. The product's dosage form is syrup and is administered via oral form.

    Is NDC 64679-604 included in the NDC Directory?

    Yes, Promethazine Hydrochloride And Dextromethorphan Hydrobromide with product code 64679-604 is active and included in the NDC Directory. The product was first marketed by Wockhardt Usa Llc. on January 04, 1985 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 64679-604-16?

    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 64679-604-16?

    The 11-digit format is 64679060416. 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
    5-3-264679-604-165-4-264679-0604-16