Diphenhydramine Hydrochloride
NDC Package 50436-3594-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours adults and children 12 years and over:ask a doctor children under 12 years:. Marketed by Unit Dose Services, this product is identified by NDC 50436-3594 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
50436-3594-1
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
50436-3594
11-Digit Billing Format
50436359401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Dosage Form
-
Usage Information
Take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours adults and children 12 years and over:ask a doctor children under 12 years:

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-24-2007
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50436-3594-1 identifies a specific commercial package of 30 capsule in 1 bottle of Diphenhydramine Hydrochloride, labeled by Unit Dose Services. 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 Unit Dose Services on May 24, 2007. The current certification is valid through December 31, 2019.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436359401. 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)
50436-3594-1
11-Digit CMS (5-4-2)
50436-3594-01

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