Hyoscyamine Sulfate Tablet
NDC Package 69367-678-01

11-digit billing NDC: 69367067801 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hyoscyamine Sulfate tablets is hyoscyamine Sulfate Sublingual Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. This formulation utilizes a tablet delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-678.

Identification & Billing

NDC Package Code
69367-678-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
69367-678
11-Digit Billing Format
69367067801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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 SL
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYOSCYAMINE SULFATE .125 mg/1
Usage Information
Hyoscyamine Sulfate Sublingual Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, 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). Hyoscyamine Sulfate Sublingual Tablets are 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
Westminster Pharmaceuticals, Llc
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
04-02-2025
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 69367-678-01 identifies a specific commercial package of 100 tablet in 1 bottle of Hyoscyamine Sulfate SL, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet 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 Westminster Pharmaceuticals, Llc on April 02, 2025. The current certification is valid through December 31, 2026.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367067801. 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)
69367-678-01
11-Digit CMS (5-4-2)
69367-0678-01

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