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  5. NDC Package Code: 50383-805-04 Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate

NDC Package 50383-805-04 Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
50383-805-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
50383-805
Proprietary Name:
Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate
Non-Proprietary Name:
Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate
Substance Name:
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride
Usage Information:
Promethazine HCl, phenylephrine HCl and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
11-Digit NDC Billing Format:
50383080504
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
118 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 996757 - codeine phosphate 10 MG / phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
  • RxCUI: 996757 - codeine phosphate 2 MG/ML / phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 996757 - codeine phosphate 10 MG / phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Akorn
    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):
  • CODEINE PHOSPHATE 10 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL
  • PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule V (CV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040674
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-16-2015
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50383-805-16473 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50383-805-04?

    The NDC Packaged Code 50383-805-04 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate, a human prescription drug labeled by Akorn. The product's dosage form is solution and is administered via oral form.

    Is NDC 50383-805 included in the NDC Directory?

    Yes, Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate with product code 50383-805 is active and included in the NDC Directory. The product was first marketed by Akorn on June 16, 2015 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 50383-805-04?

    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 118.

    What is the 11-digit format for NDC 50383-805-04?

    The 11-digit format is 50383080504. 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
    5-3-250383-805-045-4-250383-0805-04