Hyoscyamine Sulfate
NDC Package 69189-0307-1

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 inactivated by the FDA.

Hyoscyamine Sulfate is hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. Marketed by Avera Mckennan Hospital, this product is identified by NDC 69189-0307.

Identification & Billing

NDC Package Code
69189-0307-1
Package Description
1 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK
Product Code
69189-0307
11-Digit Billing Format
69189030701
RxNorm Crosswalk
RxCUI: 1046985 - hyoscyamine sulfate 0.125 MG Disintegrating Oral Tablet

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
Avera Mckennan Hospital
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
03-04-2015
Listing Expiration
12-31-2017
Exclude Flag
I
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 69189-0307-1 identifies a specific commercial package of 1 tablet, orally disintegrating in 1 dose pack of Hyoscyamine Sulfate, labeled by Avera Mckennan Hospital. 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 Avera Mckennan Hospital on March 04, 2015. The current certification is valid through December 31, 2017.

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 Avera Mckennan Hospital product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69189030701. 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 (5-4-1)
69189-0307-1
11-Digit CMS (5-4-2)
69189-0307-01

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