Hyoscyamine Sulfate Extended-release
NDC Package 33261-907-99

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 Extended-release is tablets are effective as adjunctive therapy in the treatment of peptic ulcer. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-907.

Identification & Billing

NDC Package Code
33261-907-99
Package Description
180 TABLET in 1 BOTTLE, PLASTIC
Product Code
33261-907
11-Digit Billing Format
33261090799
RxNorm Crosswalk
  • RxCUI: 1046770 - hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1046770 - 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
  • RxCUI: 1046770 - hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 1046770 - hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Hyoscyamine Sulfate Extended-release
Dosage Form
-
Usage Information
Hyoscyamine Sulfate Extended-Release 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 Extended-Release 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
Aidarex Pharmaceuticals Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-03-2010
Listing Expiration
12-31-2019
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 33261-907-99 identifies a specific commercial package of 180 tablet in 1 bottle, plastic of Hyoscyamine Sulfate Extended-release, labeled by Aidarex Pharmaceuticals Llc. 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 Aidarex Pharmaceuticals Llc on January 03, 2010. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261090799. 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)
33261-907-99
11-Digit CMS (5-4-2)
33261-0907-99

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