Diazepam Gel
NDC Package 68682-655-20

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

Package Information

Diazepam gel is diazepam is used to treat anxiety, alcohol withdrawal, and seizures. This formulation utilizes a gel delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-655 and is authorized under FDA application NDA020648.

Identification & Billing

NDC Package Code
68682-655-20
Package Description
2 SYRINGE, PLASTIC in 1 PACKAGE / 4 mL in 1 SYRINGE, PLASTIC
Product Code
68682-655
11-Digit Billing Format
68682065520
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diazepam
Non-Proprietary Name
Diazepam
Substance Name
Diazepam
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
DIAZEPAM 20 mg/4mL
Pharmacologic Class
Usage Information
Diazepam is used to treat anxiety, alcohol withdrawal, and seizures. It is also used to relieve muscle spasms and to provide sedation before medical procedures. This medication works by calming the brain and nerves. Diazepam belongs to a class of drugs known as benzodiazepines.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA020648
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-29-1997
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 68682-655-20 identifies a specific commercial package of 2 syringe, plastic in 1 package / 4 ml in 1 syringe, plastic of Diazepam, a human prescription drug labeled by Oceanside Pharmaceuticals. This gel is formulated for rectal use and contains diazepam 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 Oceanside Pharmaceuticals on July 29, 1997. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diazepam is used to treat anxiety, alcohol withdrawal, and seizures. It is also used to relieve muscle spasms and to provide sedation before medical procedures. This medication works by calming the brain and nerves. Diazepam belongs to a class of drugs known as benzodiazepines.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682065520. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
68682-655-20
11-Digit CMS (5-4-2)
68682-0655-20

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