Diphenhydramine Hydrochloride
NDC Package 65437-036-07

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.

Diphenhydramine Hydrochloride is take every 4 to 6 hoursdo not take more than 6 times in 24 hoursadults and children 12 years and over1 to 2 tabletschildren 6 to under 12 years1 tabletchildren under 6 yearsdo not use this product in children under 6 years of age. Marketed by Himprit Pharmachem Pvt Ltd, this product is identified by NDC 65437-036 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
65437-036-07
Package Description
1 BAG in 1 DRUM / 75000 TABLET, FILM COATED in 1 BAG
Product Code
65437-036
11-Digit Billing Format
65437003607
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Dosage Form
-
Usage Information
Take every 4 to 6 hoursdo not take more than 6 times in 24 hoursadults and children 12 years and over1 to 2 tabletschildren 6 to under 12 years1 tabletchildren under 6 yearsdo not use this product in children under 6 years of age

Regulatory & Marketing

Labeler Name
Himprit Pharmachem Pvt Ltd
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-01-2010
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 (65437-036). Click a package code to view its specific billing and regulatory data.

65437-036-05
1 BAG in 1 DRUM / 50000 TABLET, FILM COATED in 1 BAG
65437-036-10
1 BAG in 1 DRUM / 100000 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 65437-036-07 identifies a specific commercial package of 1 bag in 1 drum / 75000 tablet, film coated in 1 bag of 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 March 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: 65437003607. 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)
65437-036-07
11-Digit CMS (5-4-2)
65437-0036-07

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