Dextroamphetamine Sulfate Capsule, Extended Release
NDC Package 0115-9929-10
Package Information
Dextroamphetamine Sulfate capsules is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a capsule, extended release delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-9929 and is authorized under FDA application NDA017078.
Identification & Billing
- RxCUI: 884520 - dextroamphetamine sulfate 10 MG Extended Release Oral Capsule
- RxCUI: 884532 - dextroamphetamine sulfate 15 MG Extended Release Oral Capsule
- RxCUI: 884535 - dextroamphetamine sulfate 5 MG Extended Release Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0115 - Amneal Pharmaceuticals Of New York Llc
- 0115-9929 - Dextroamphetamine Sulfate
- 0115-9929-10 - 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
- 0115-9929 - Dextroamphetamine Sulfate
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0115-9929-10 identifies a specific commercial package of 90 capsule, extended release in 1 bottle of Dextroamphetamine Sulfate Extended-release, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This capsule, extended release is formulated for oral use and contains dextroamphetamine sulfate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Of New York Llc on August 02, 1976. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dextroamphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills. This medication is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.
How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115992910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.