Mixed Salts Of A Single-entity Amphetamine Product Capsule, Extended Release
NDC Package 0406-0804-01

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

Package Information

Mixed Salts Of A Single-entity Amphetamine Product (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate) capsules is mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Specgx Llc, this product is identified by NDC 0406-0804 and is authorized under FDA application ANDA211546.

Identification & Billing

NDC Package Code
0406-0804-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0406-0804
11-Digit Billing Format
00406080401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1927610 - amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule
  • RxCUI: 1927610 - 3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule
  • RxCUI: 1927617 - amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule
  • RxCUI: 1927617 - 3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule
  • RxCUI: 1927630 - amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Mixed Salts Of A Single-entity Amphetamine Product
Non-Proprietary Name
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
Substance Name
Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Specgx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211546
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2023
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 0406-0804-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Mixed Salts Of A Single-entity Amphetamine Product, a human prescription drug labeled by Specgx Llc. This capsule, extended release is formulated for oral use and contains amphetamine aspartate monohydrate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 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 Specgx Llc on November 01, 2023. The current certification is valid through December 31, 2026.

How is this Specgx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00406080401. 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 (4-4-2)
0406-0804-01
11-Digit CMS (5-4-2)
00406-0804-01

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