Hyoscyamine Sulfate
NDC Package 0603-1315-58

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hyoscyamine Sulfate is hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. Marketed by Qualitest Pharmaceuticals, Inc, this product is identified by NDC 0603-1315.

Identification & Billing

NDC Package Code
0603-1315-58
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0603-1315
11-Digit Billing Format
00603131558

Clinical Specifications

Proprietary Name
Hyoscyamine Sulfate
Dosage Form
-
Usage Information
Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is also used to treat other conditions such as bladder and bowel control problems, cramping pain caused by kidney stones and gallstones, and Parkinson's disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides. This medication works by decreasing acid production in the stomach, slowing down the natural movements of the gut, and relaxing muscles in many organs (such as the stomach, intestines, bladder, kidney, gallbladder). Hyoscyamine also lessens the amount of certain body fluids (e.g., saliva, sweat). This medication belongs to a class of drugs known as anticholinergics/antispasmodics.

Regulatory & Marketing

Labeler Name
Qualitest Pharmaceuticals, Inc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-01-1997
End Marketing Date
12-01-2010
Listing Expiration
12-01-2010
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0603-1315-58 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Hyoscyamine Sulfate, labeled by Qualitest Pharmaceuticals, Inc. 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 Qualitest Pharmaceuticals, Inc on November 01, 1997. The current certification is valid through December 01, 2010.

What are the primary indications for this medication?

Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is also used to treat other conditions such as bladder and bowel control problems, cramping pain caused by kidney stones and gallstones, and Parkinson's disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides. This medication works by decreasing acid production in the stomach, slowing down the natural movements of the gut, and relaxing muscles in many organs (such as the stomach, intestines, bladder, kidney, gallbladder). Hyoscyamine also lessens the amount of certain body fluids (e.g., saliva, sweat). This medication belongs to a class of drugs known as anticholinergics/antispasmodics.

How is this Qualitest Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00603131558. 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 (4-4-2)
0603-1315-58
11-Digit CMS (5-4-2)
00603-1315-58

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