Hyoscyamine Sulfate Tablet
NDC Package 0615-8554-39

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

Package Information

Hyoscyamine Sulfate tablets is hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. This formulation utilizes a tablet delivery system. Marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-8554.

Identification & Billing

NDC Package Code
0615-8554-39
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
0615-8554
11-Digit Billing Format
00615855439
RxNorm Crosswalk
  • RxCUI: 1046982 - hyoscyamine sulfate 0.125 MG Sublingual Tablet
  • RxCUI: 1046982 - hyoscyamine sulfate SL 0.125 Disintegrating Sublingual Tablet

Clinical Specifications

Proprietary Name
Hyoscyamine Sulfate
Non-Proprietary Name
Hyoscyamine Sulfate
Substance Name
Hyoscyamine Sulfate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
HYOSCYAMINE SULFATE .125 mg/1
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
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-15-2024
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0615-8554-39 identifies a specific commercial package of 30 tablet in 1 blister pack of Hyoscyamine Sulfate, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. This tablet is formulated for sublingual use and contains hyoscyamine 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs on February 15, 2024. The current certification is valid through December 31, 2026.

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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615855439. 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)
0615-8554-39
11-Digit CMS (5-4-2)
00615-8554-39

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