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  5. NDC Package Code: 69238-1422-4 Naproxen Sodium And Diphenhydramine Hcl

NDC Package 69238-1422-4 Naproxen Sodium And Diphenhydramine Hcl

Naproxen Sodium And Diphenhydramine 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:
69238-1422-4
Package Description:
1 BOTTLE in 1 CARTON / 40 TABLET, FILM COATED in 1 BOTTLE
Product Code:
69238-1422
Proprietary Name:
Naproxen Sodium And Diphenhydramine Hcl
Non-Proprietary Name:
Naproxen Sodium And Diphenhydramine
Substance Name:
Diphenhydramine Hydrochloride; Naproxen Sodium
Usage Information:
Do not take more than directed drink a full glass of water with each doseadults and children 12 years and over: take 2 tablets at bedtimedo not take more than 2 tablets in 24 hoursif taken with food, this product may take longer to work
11-Digit NDC Billing Format:
69238142204
NDC to RxNorm Crosswalk:
  • RxCUI: 1550957 - diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral Tablet
  • RxCUI: 1550957 - diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Amneal Pharmaceuticals Ny Llc
    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):
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
  • NAPROXEN SODIUM 220 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209726
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-23-2018
    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
    69238-1422-21 BOTTLE in 1 CARTON / 20 TABLET, FILM COATED in 1 BOTTLE
    69238-1422-61 BOTTLE in 1 CARTON / 160 TABLET, FILM COATED in 1 BOTTLE
    69238-1422-81 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69238-1422-4?

    The NDC Packaged Code 69238-1422-4 is assigned to a package of 1 bottle in 1 carton / 40 tablet, film coated in 1 bottle of Naproxen Sodium And Diphenhydramine Hcl, a human over the counter drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 69238-1422 included in the NDC Directory?

    Yes, Naproxen Sodium And Diphenhydramine Hcl with product code 69238-1422 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on October 23, 2018 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 11-digit format for NDC 69238-1422-4?

    The 11-digit format is 69238142204. 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 5-4-1 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
    5-4-169238-1422-45-4-269238-1422-04