Acetaminophen And Diphenhydramine Hydrochloride
NDC Package 65437-041-31

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Acetaminophen And Diphenhydramine Hydrochloride is a medication used as Active ingredients (in each Caplet)PurposeAcetaminophen 500 mgPain reliever/ fever reducerDiphenhydramine HCL 25 mgSleep Aid. Marketed by Himprit Pharmachem Pvt Ltd, this product is identified by NDC 65437-041 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
65437-041-31
Package Description
1 BAG in 1 DRUM / 31000 TABLET, FILM COATED in 1 BAG
Product Code
65437-041
11-Digit Billing Format
65437004131
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

Clinical Specifications

Proprietary Name
Acetaminophen And Diphenhydramine Hydrochloride
Dosage Form
-
Usage Information
This product is used as Active ingredients (in each Caplet)PurposeAcetaminophen 500 mgPain reliever/ fever reducerDiphenhydramine HCL 25 mgSleep Aid. Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness

Regulatory & Marketing

Labeler Name
Himprit Pharmachem Pvt Ltd
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
07-01-2010
Listing Expiration
12-31-2018
Exclude Flag
I
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 (65437-041). Click a package code to view its specific billing and regulatory data.

65437-041-50
1 BAG in 1 DRUM / 50000 TABLET, FILM COATED in 1 BAG

* 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 65437-041-31 identifies a specific commercial package of 1 bag in 1 drum / 31000 tablet, film coated in 1 bag of Acetaminophen And Diphenhydramine Hydrochloride, labeled by Himprit Pharmachem Pvt Ltd. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Himprit Pharmachem Pvt Ltd on July 01, 2010. The current certification is valid through December 31, 2018.

How is this Himprit Pharmachem Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65437004131. 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 (5-3-2)
65437-041-31
11-Digit CMS (5-4-2)
65437-0041-31

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