Somnapure Tablet, Coated
NDC Package 69721-005-30

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

Package Information

Somnapure (diphenhydramine hydrochloride) tablets is Use helps to reduce difficulty in falling asleep. This formulation utilizes a tablet, coated delivery system. Marketed by Force Factor Brands Llc, this product is identified by NDC 69721-005 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
69721-005-30
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, COATED in 1 BOTTLE
Product Code
69721-005
11-Digit Billing Format
69721000530
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Somnapure Clinical Strength
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
Pharmacologic Class
Usage Information
Use helps to reduce difficulty in falling asleep

Regulatory & Marketing

Labeler Name
Force Factor Brands Llc
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-20-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69721-005-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, coated in 1 bottle of Somnapure Clinical Strength, a human over the counter drug labeled by Force Factor Brands Llc. This tablet, coated is formulated for oral use and contains diphenhydramine hydrochloride 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 Force Factor Brands Llc on March 20, 2018. The current certification is valid through December 31, 2026.

How is this Force Factor Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69721000530. 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)
69721-005-30
11-Digit CMS (5-4-2)
69721-0005-30

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