Amphetamine Sulfate Tablet
NDC Package 52536-059-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Amphetamine Sulfate tablets is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a tablet delivery system. Marketed by Wilshire Pharmaceuticals, Inc., this product is identified by NDC 52536-059 and is authorized under FDA application ANDA200166.

Identification & Billing

NDC Package Code
52536-059-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
52536-059
11-Digit Billing Format
52536005910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amphetamine Sulfate
Non-Proprietary Name
Amphetamine Sulfate
Substance Name
Amphetamine Sulfate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMPHETAMINE SULFATE 10 mg/1
Pharmacologic Class
Usage Information
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Wilshire Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200166
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2018
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52536-059). Click a package code to view its specific billing and regulatory data.

52536-059-03
30 TABLET in 1 BOTTLE

* 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 52536-059-10 identifies a specific commercial package of 100 tablet in 1 bottle of Amphetamine Sulfate, a human prescription drug labeled by Wilshire Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains amphetamine 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 Wilshire Pharmaceuticals, Inc. on March 29, 2018. The current certification is valid through December 31, 2027.

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 Wilshire Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52536005910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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:

10-Digit Format (5-3-2)
52536-059-10
11-Digit CMS (5-4-2)
52536-0059-10

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