Naproxen Sodium And Diphenhydramine Hcl Tablet, Film Coated
NDC Package 69238-1422-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Naproxen Sodium And Diphenhydramine Hcl (naproxen sodium and diphenhydramine) tablets is 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-1422 and is authorized under FDA application ANDA209726.

Identification & Billing

NDC Package Code
69238-1422-2
Package Description
1 BOTTLE in 1 CARTON / 20 TABLET, FILM COATED in 1 BOTTLE
Product Code
69238-1422
11-Digit Billing Format
69238142202
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

Clinical Specifications

Proprietary Name
Naproxen Sodium And Diphenhydramine Hcl
Non-Proprietary Name
Naproxen Sodium And Diphenhydramine
Substance Name
Diphenhydramine Hydrochloride; Naproxen Sodium
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Otc Drug
FDA Application #
ANDA209726
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-23-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69238-1422). Click a package code to view its specific billing and regulatory data.

69238-1422-4
1 BOTTLE in 1 CARTON / 40 TABLET, FILM COATED in 1 BOTTLE
69238-1422-6
1 BOTTLE in 1 CARTON / 160 TABLET, FILM COATED in 1 BOTTLE
69238-1422-8
1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69238-1422-2 identifies a specific commercial package of 1 bottle in 1 carton / 20 tablet, film coated in 1 bottle of Naproxen Sodium And Diphenhydramine Hcl, a human over the counter drug labeled by Amneal Pharmaceuticals Ny Llc. This tablet, film coated is formulated for oral use and contains diphenhydramine hydrochloride; naproxen sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Ny Llc on October 23, 2018. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238142202. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
69238-1422-2
11-Digit CMS (5-4-2)
69238-1422-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.