Lisdexamfetamine Dimesylate Capsule
NDC Package 0378-6858-77

11-digit billing NDC: 00378685877 · Billing unit: EA · 90 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lisdexamfetamine Dimesylate (lisdexamfetamine) capsules is lisdexamfetamine dimesylate capsules 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 capsules is 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 capsules are not indicated or recommended for weight loss. This formulation utilizes a capsule delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-6858 and is authorized under FDA application ANDA202835.

Identification & Billing

NDC Package Code
0378-6858-77
Package Description
90 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
0378-6858
11-Digit Billing Format
00378685877
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lisdexamfetamine Dimesylate
Non-Proprietary Name
Lisdexamfetamine
Substance Name
Lisdexamfetamine Dimesylate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LISDEXAMFETAMINE DIMESYLATE 50 mg/1
Pharmacologic Class
Usage Information
Lisdexamfetamine dimesylate capsules 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 capsules is 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 capsules 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 capsules 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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202835
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 0378-6858-77 identifies a specific commercial package of 90 capsule in 1 bottle, plastic of Lisdexamfetamine Dimesylate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This capsule 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 Mylan Pharmaceuticals Inc. on August 25, 2023. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378685877. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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 (4-4-2)
0378-6858-77
11-Digit CMS (5-4-2)
00378-6858-77

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