Lisdexamfetamine Dimesylate Tablet, Chewable
NDC Package 31722-321-01

11-digit billing NDC: 31722032101 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lisdexamfetamine Dimesylate tablets is lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of:Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)].Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].Limitations of Use:The use of lisdexamfetamine dimesylate chewable tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)].Lisdexamfetamine dimesylate are not indicated or recommended for weight loss. This formulation utilizes a tablet, chewable delivery system. Marketed by Camber Pharmaceuticals, Inc., this product is identified by NDC 31722-321 and is authorized under FDA application ANDA217068.

Identification & Billing

NDC Package Code
31722-321-01
Package Description
100 TABLET, CHEWABLE in 1 BOTTLE
Product Code
31722-321
11-Digit Billing Format
31722032101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lisdexamfetamine Dimesylate
Non-Proprietary Name
Lisdexamfetamine Dimesylate
Substance Name
Lisdexamfetamine Dimesylate
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LISDEXAMFETAMINE DIMESYLATE 10 mg/1
Pharmacologic Class
Usage Information
Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of:Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)].Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].Limitations of Use:The use of lisdexamfetamine dimesylate chewable tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)].Lisdexamfetamine dimesylate are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate for the treatment of obesity have not been established [see Warnings and Precautions (5.2)]
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Camber Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217068
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-25-2023
Listing Expiration
12-31-2027
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 31722-321-01 identifies a specific commercial package of 100 tablet, chewable in 1 bottle of Lisdexamfetamine Dimesylate, a human prescription drug labeled by Camber Pharmaceuticals, Inc.. This tablet, chewable is formulated for oral use and contains lisdexamfetamine dimesylate 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 Camber Pharmaceuticals, Inc. on August 25, 2023. The current certification is valid through December 31, 2027.

How is this Camber Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31722032101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
31722-321-01
11-Digit CMS (5-4-2)
31722-0321-01

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