Nightime Sleep Aid Capsule, Liquid Filled
NDC Package 76168-065-37

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

Package Information

Nightime Sleep Aid (diphenhydramine) capsules is adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.children under 12 years:do not use. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Velocity Pharma, this product is identified by NDC 76168-065 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
76168-065-37
Package Description
16 CARTON in 1 BOTTLE / 1 CAPSULE, LIQUID FILLED in 1 CARTON
Product Code
76168-065
11-Digit Billing Format
76168006537
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nightime Sleep Aid
Non-Proprietary Name
Diphenhydramine
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.children under 12 years:do not use

Regulatory & Marketing

Labeler Name
Velocity Pharma
Product Type
Human Otc Drug
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-31-2014
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 76168-065-37 identifies a specific commercial package of 16 carton in 1 bottle / 1 capsule, liquid filled in 1 carton of Nightime Sleep Aid, a human over the counter drug labeled by Velocity Pharma. This capsule, liquid filled 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 Velocity Pharma on March 31, 2014. The current certification is valid through December 31, 2026.

How is this Velocity Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76168006537. 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)
76168-065-37
11-Digit CMS (5-4-2)
76168-0065-37

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