Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Capsule, Extended Release
NDC Package 0480-3685-01

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

Package Information

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate capsules is dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].Limitations of Use Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-3685 and is authorized under FDA application ANDA210876.

Identification & Billing

NDC Package Code
0480-3685-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0480-3685
11-Digit Billing Format
00480368501
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
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Non-Proprietary Name
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And 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
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].Limitations of Use Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210876
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-10-2023
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 0480-3685-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. 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 Teva Pharmaceuticals, Inc. on October 10, 2023. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480368501. 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)
0480-3685-01
11-Digit CMS (5-4-2)
00480-3685-01

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