Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
NDC Package 68382-950-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate is dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-950 and is authorized under FDA application ANDA207340.

Identification & Billing

NDC Package Code
68382-950-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
68382-950
11-Digit Billing Format
68382095001
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: 1009145 - dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral Tablet
  • RxCUI: 1009145 - amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral Tablet
  • RxCUI: 1009145 - mixed amphetamine salts 7.5 MG Oral Tablet
  • RxCUI: 541363 - dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral Tablet
  • RxCUI: 541363 - amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Dosage Form
-
Usage Information
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
FDA Application #
ANDA207340
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2017
Listing Expiration
12-31-2021
Exclude Flag
I
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 68382-950-01 identifies a specific commercial package of 100 tablet in 1 bottle of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate, labeled by Zydus Pharmaceuticals (usa) Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Zydus Pharmaceuticals (usa) Inc. on October 31, 2017. The current certification is valid through December 31, 2021.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382095001. 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)
68382-950-01
11-Digit CMS (5-4-2)
68382-0950-01

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