Hyosyne Elixir
NDC Package 54838-511-80

11-digit billing NDC: 54838051180 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hyosyne (hyoscyamine sulfate) elixirs is hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. This formulation utilizes a elixir delivery system. Marketed by Lannett Company, Inc., this product is identified by NDC 54838-511.

Identification & Billing

NDC Package Code
54838-511-80
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
54838-511
11-Digit Billing Format
54838051180
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hyosyne
Non-Proprietary Name
Hyoscyamine Sulfate
Substance Name
Hyoscyamine Sulfate
Dosage Form
Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYOSCYAMINE SULFATE .125 mg/5mL
Usage Information
Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon,mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.

Regulatory & Marketing

Labeler Name
Lannett Company, Inc.
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
11-01-1997
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 54838-511-80 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Hyosyne, a human prescription drug labeled by Lannett Company, Inc.. This elixir is formulated for oral 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 Lannett Company, Inc. on November 01, 1997. The current certification is valid through December 31, 2026.

How is this Lannett Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54838051180. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
54838-511-80
11-Digit CMS (5-4-2)
54838-0511-80

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