Sympazan Film
NDC Package 10094-210-60

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

Package Information

Sympazan (clobazam) films is a medication used with other medications to help control seizures. This formulation utilizes a film delivery system. Marketed by Aquestive Therapeutics, this product is identified by NDC 10094-210 and is authorized under FDA application NDA210833.

Identification & Billing

NDC Package Code
10094-210-60
Package Description
60 POUCH in 1 PACKAGE / 1 FILM in 1 POUCH (10094-210-01)
Product Code
10094-210
11-Digit Billing Format
10094021060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sympazan
Non-Proprietary Name
Clobazam
Substance Name
Clobazam
Dosage Form
Film - A thin layer or coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLOBAZAM 10 mg/1
Pharmacologic Class
Usage Information
This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Aquestive Therapeutics
Product Type
Human Prescription Drug
FDA Application #
NDA210833
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2018
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 10094-210-60 identifies a specific commercial package of 60 pouch in 1 package / 1 film in 1 pouch (10094-210-01) of Sympazan, a human prescription drug labeled by Aquestive Therapeutics. This film is formulated for oral use and contains clobazam 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 Aquestive Therapeutics on November 01, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

How is this Aquestive Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10094021060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
10094-210-60
11-Digit CMS (5-4-2)
10094-0210-60

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