Amphetamine Sulfate
NDC Package 67877-710-01
Package Information
Amphetamine Sulfate is a medication used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Ascend Laboratories, Llc, this product is identified by NDC 67877-710 and is authorized under FDA application ANDA213720.
Identification & Billing
- RxCUI: 1600695 - amphetamine sulfate 10 MG Oral Tablet
- RxCUI: 884655 - amphetamine sulfate 5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 67877 - Ascend Laboratories, Llc
- 67877-710 - Amphetamine Sulfate
- 67877-710-01 - 100 TABLET in 1 BOTTLE
- 67877-710 - Amphetamine 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 67877-710-01 identifies a specific commercial package of 100 tablet in 1 bottle of Amphetamine Sulfate, labeled by Ascend Laboratories, Llc. 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 Ascend Laboratories, Llc on October 29, 2020. The current certification is valid through December 31, 2024.
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. Amphetamine 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. Amphetamine may also be used along with a doctor-approved, reduced-calorie diet to help significantly overweight (obese) people lose weight. It should only be used for a short time (a few weeks) in people who have not lost enough weight with other treatments (such as dieting, other drugs, group programs). It may work by decreasing your appetite.
How is this Ascend Laboratories, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877071001. 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 Product segment to maintain the 5-4-2 structure.