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  5. NDC Package Code: 50580-833-01 Tylenol Pm Extra Strength

NDC Package 50580-833-01 Tylenol Pm Extra Strength

Acetaminophen And Diphenhydramine Hydrochloride 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:
50580-833-01
Package Description:
240 mL in 1 BOTTLE
Product Code:
50580-833
Proprietary Name:
Tylenol Pm Extra Strength
Non-Proprietary Name:
Acetaminophen And Diphenhydramine Hydrochloride
Substance Name:
Acetaminophen; Diphenhydramine Hydrochloride
Usage Information:
Do not take more than directed (see overdose warning)mL = milliliteruse only enclosed dosing cup designed for use with this product. Do not use any other dosing device.adults and children 12 years and overtake 30 mL in the dosing cup provided at bedtimedo not take more than 30 mL of this product in 24 hourschildren under 12 yearsdo not use
11-Digit NDC Billing Format:
50580083301
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
240 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1092373 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral Solution
  • RxCUI: 1092373 - acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral Solution
  • RxCUI: 1092373 - acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral Solution
  • RxCUI: 1092373 - acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral Solution
  • RxCUI: 1092373 - APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer 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):
  • ACETAMINOPHEN 1000 mg/30mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M013
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-25-2018
    Listing Expiration Date:
    12-31-2025
    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 50580-833-01?

    The NDC Packaged Code 50580-833-01 is assigned to a package of 240 ml in 1 bottle of Tylenol Pm Extra Strength, a human over the counter drug labeled by Johnson & Johnson Consumer Inc.. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 240 billable units per package.

    Is NDC 50580-833 included in the NDC Directory?

    Yes, Tylenol Pm Extra Strength with product code 50580-833 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on June 25, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50580-833-01?

    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 240.

    What is the 11-digit format for NDC 50580-833-01?

    The 11-digit format is 50580083301. 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
    5-3-250580-833-015-4-250580-0833-01