Lisdexamfetamine Dimesylate Capsule
NDC Package 43547-607-10

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

Package Information

Lisdexamfetamine Dimesylate (lisdexamfetamine dimesylate capsules) capsules is lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. This formulation utilizes a capsule delivery system. Marketed by Solco Healthcare Us,llc, this product is identified by NDC 43547-607 and is authorized under FDA application ANDA216266.

Identification & Billing

NDC Package Code
43547-607-10
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
43547-607
11-Digit Billing Format
43547060710
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 Capsules
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 60 mg/1
Pharmacologic Class
Usage Information
Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, stay focused, and stop fidgeting. Lisdexamfetamine may also be used to treat binge eating disorder (BED). It may help to reduce the number of binge eating days. This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain. This medication is not recommended for use for weight loss due to the risk of serious side effects.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Solco Healthcare Us,llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216266
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-26-2023
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 43547-607-10 identifies a specific commercial package of 100 capsule in 1 bottle of Lisdexamfetamine Dimesylate, a human prescription drug labeled by Solco Healthcare Us,llc. 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 Solco Healthcare Us,llc on August 26, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, stay focused, and stop fidgeting. Lisdexamfetamine may also be used to treat binge eating disorder (BED). It may help to reduce the number of binge eating days. This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain. This medication is not recommended for use for weight loss due to the risk of serious side effects.

How is this Solco Healthcare Us,llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43547060710. 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)
43547-607-10
11-Digit CMS (5-4-2)
43547-0607-10

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