NDC 0115-1329 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0115-1329
Proprietary Name:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Labeler Code:
0115
Start Marketing Date: [9]
12-17-2013
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - CLEAR, BLUE)
BLUE (C48333)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
M;AMPHET;SALTS;5;MG
M;AMPHET;SALTS;10;MG
Score:
1

Product Packages

NDC Code 0115-1329-01

Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $1.78648 per EA

Product Details

What is NDC 0115-1329?

The NDC code 0115-1329 is assigned by the FDA to the product Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate which is product labeled by Global Pharmaceuticals, Division Of Impax Laboratories Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0115-1329-01 100 capsule, extended release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate?

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)]

Which are Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".