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  5. NDC Package Code: 50580-608-01 Tylenol Pm Extra Strength

NDC Package 50580-608-01 Tylenol Pm Extra Strength

Acetaminophen And Diphenhydramine Hydrochloride Tablet, Film Coated 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:
50580-608-01
Package Description:
1 BOTTLE in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE
Product Code:
50580-608
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)adults and children 12 years and overtake 2 caplets at bedtimedo not take more than 2 caplets of this product in 24 hourschildren under 12 yearsdo not use
11-Digit NDC Billing Format:
50580060801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092378 - Tylenol PM 500 MG / 25 MG Oral Tablet
  • RxCUI: 1092378 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 500 mg/1
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
    • 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:
    07-11-2016
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50580-608-021 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
    50580-608-031 BOTTLE in 1 CARTON / 150 TABLET, FILM COATED in 1 BOTTLE
    50580-608-041 BOTTLE in 1 CARTON / 225 TABLET, FILM COATED in 1 BOTTLE
    50580-608-052 TABLET, FILM COATED in 1 POUCH
    50580-608-0650 POUCH in 1 TRAY / 2 TABLET, FILM COATED in 1 POUCH
    50580-608-072 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH
    50580-608-081 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50580-608-01?

    The NDC Packaged Code 50580-608-01 is assigned to a package of 1 bottle in 1 carton / 24 tablet, film coated 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 tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 50580-608 included in the NDC Directory?

    Yes, Tylenol Pm Extra Strength with product code 50580-608 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on July 11, 2016 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 50580-608-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 50580-608-01?

    The 11-digit format is 50580060801. 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
    5-3-250580-608-015-4-250580-0608-01