Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
NDC Package 0115-1333-01

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 mAS-ER Capsule administration is contraindicated in patients with the following conditions:Advanced arteriosclerosis Symptomatic cardiovascular disease Moderate to severe hypertension Hyperthyroidism Known hypersensitivity or idiosyncrasy to the sympathomimetic amines (e.g., anaphylaxis, angioedema, serious skin rashes) [see ADVERSE REACTIONS (6.2)]Glaucoma Agitated states History of drug abuse During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) [see DRUG INTERACTIONS (7.1)]. Marketed by Global Pharmaceuticals, Division Of Impax Laboratories Inc., this product is identified by NDC 0115-1333 and is authorized under FDA application NDA021303.

Identification & Billing

NDC Package Code
0115-1333-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0115-1333
11-Digit Billing Format
00115133301
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: 861221 - dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral Capsule
  • RxCUI: 861221 - 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule
  • RxCUI: 861221 - amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 861223 - dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG 24HR Extended Release Oral Capsule
  • RxCUI: 861223 - 24 HR amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Dosage Form
-
Usage Information
MAS-ER Capsule administration is contraindicated in patients with the following conditions:Advanced arteriosclerosis Symptomatic cardiovascular disease Moderate to severe hypertension Hyperthyroidism Known hypersensitivity or idiosyncrasy to the sympathomimetic amines (e.g., anaphylaxis, angioedema, serious skin rashes) [see ADVERSE REACTIONS (6.2)]Glaucoma Agitated states History of drug abuse During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) [see DRUG INTERACTIONS (7.1)]

Regulatory & Marketing

Labeler Name
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
FDA Application #
NDA021303
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-17-2013
Listing Expiration
12-31-2019
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 0115-1333-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate, labeled by Global Pharmaceuticals, Division Of Impax Laboratories 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 Global Pharmaceuticals, Division Of Impax Laboratories Inc. on December 17, 2013. The current certification is valid through December 31, 2019.

How is this Global Pharmaceuticals, Division Of Impax Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115133301. 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)
0115-1333-01
11-Digit CMS (5-4-2)
00115-1333-01

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