Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
NDC Package 70710-1189-1

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 Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate is dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules administration is contraindicated in patients with the following conditions: Advanced arteriosclerosisSymptomatic cardiovascular diseaseModerate to severe hypertensionHyperthyroidismInpatients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-1189 and is authorized under FDA application ANDA210080.

Identification & Billing

NDC Package Code
70710-1189-1
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
70710-1189
11-Digit Billing Format
70710118901
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 Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Dosage Form
-
Usage Information
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules administration is contraindicated in patients with the following conditions: Advanced arteriosclerosisSymptomatic cardiovascular diseaseModerate to severe hypertensionHyperthyroidismInpatients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2)]GlaucomaAgitated statesHistory of drug abusePatients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.6) and Drug Interactions (7.1)]

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
FDA Application #
ANDA210080
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2016
Listing Expiration
12-31-2022
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 70710-1189-1 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, 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 December 30, 2016. The current certification is valid through December 31, 2022.

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: 70710118901. 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 (5-4-1)
70710-1189-1
11-Digit CMS (5-4-2)
70710-1189-01

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