NDC 0115-1330 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate

Product Information

Product Code0115-1330
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Labeler Code0115
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-17-2013
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)BLUE (C48333 - CLEAR, BLUE)
BLUE (C48333)
WHITE (C48325)
ShapeCAPSULE (C48336)
Size(s)22 MM
25 MM
Imprint(s)M;AMPHET;SALTS;5;MG
M;AMPHET;SALTS;10;MG
M;AMPHET;SALTS;15;MG
Score1

Product Packages

NDC 0115-1330-01

Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $1.99219 per EA

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

Product Details

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate is product labeled by Global Pharmaceuticals, Division Of Impax Laboratories Inc.. The product's dosage form is and is administered via form.


What are Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N)
  • DEXTROAMPHETAMINE (UNII: TZ47U051FI) (Active Moiety)
  • DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073)
  • AMPHETAMINE SULFATE (UNII: 6DPV8NK46S)
  • AMPHETAMINE (UNII: CK833KGX7E) (Active Moiety)
  • AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4)


NDC to RxNorm Crosswalk

What is RxNorm? 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:


Inactive Ingredient(s)

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.

  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)


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Patient Education

Dextroamphetamine and Amphetamine

Dextroamphetamine and Amphetamine is pronounced as (dex troe am fet' a meen) (am fet' a meen)

Why is dextroamphetamine and amphetamine medication prescribed?
The combination of dextroamphetamine and amphetamine is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more di...
[Read More]

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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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