Diazepam Spray
NDC Package 11014-0401-2

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Diazepam sprays is a medication used to treat episodes of increased seizures (such as cluster or breakthrough seizures) in people who are already taking medications to control their seizures. This formulation utilizes a spray delivery system. Marketed by Catalent Pharma Solutions, Llc, this product is identified by NDC 11014-0401.

Identification & Billing

NDC Package Code
11014-0401-2
Package Description
65 VIAL in 1 CARTON / 100 uL in 1 VIAL
Product Code
11014-0401
11-Digit Billing Format
11014040102

Clinical Specifications

Proprietary Name
Diazepam
Non-Proprietary Name
Diazepam
Substance Name
Diazepam
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Active Ingredient(s)
DIAZEPAM 10 mg/100uL
Usage Information
This medication is used to treat episodes of increased seizures (such as cluster or breakthrough seizures) in people who are already taking medications to control their seizures. This product is only recommended for short-term treatment of seizure attacks. It is not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus). This medication is not recommended for children younger than 6 months of age because of the risk of serious side effects. Diazepam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Catalent Pharma Solutions, Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-05-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 11014-0401-2 identifies a specific commercial package of 65 vial in 1 carton / 100 ul in 1 vial of Diazepam (UNFINISHED drug), drug for further processing labeled by Catalent Pharma Solutions, Llc. This spray is formulated for 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 Catalent Pharma Solutions, Llc on September 05, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat episodes of increased seizures (such as cluster or breakthrough seizures) in people who are already taking medications to control their seizures. This product is only recommended for short-term treatment of seizure attacks. It is not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus). This medication is not recommended for children younger than 6 months of age because of the risk of serious side effects. Diazepam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.

How is this Catalent Pharma Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11014040102. 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)
11014-0401-2
11-Digit CMS (5-4-2)
11014-0401-02

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