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  5. NDC Package Code: 42192-338-01 Hyoscyamine Sulfate Odt

NDC Package 42192-338-01 Hyoscyamine Sulfate Odt

Hyoscyamine Sulfate Tablet, Orally Disintegrating Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
42192-338-01
Package Description:
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code:
42192-338
Proprietary Name:
Hyoscyamine Sulfate Odt
Non-Proprietary Name:
Hyoscyamine Sulfate
Substance Name:
Hyoscyamine Sulfate
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.
11-Digit NDC Billing Format:
42192033801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1046985 - hyoscyamine sulfate 0.125 MG Disintegrating Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Acella Pharmaceuticals, Llc
    Dosage Form:
    Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYOSCYAMINE SULFATE .125 mg/1
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    05-19-2011
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 42192-338-01?

    The NDC Packaged Code 42192-338-01 is assigned to a package of 100 tablet, orally disintegrating in 1 bottle of Hyoscyamine Sulfate Odt, a human prescription drug labeled by Acella Pharmaceuticals, Llc. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

    Is NDC 42192-338 included in the NDC Directory?

    Yes, Hyoscyamine Sulfate Odt with product code 42192-338 is active and included in the NDC Directory. The product was first marketed by Acella Pharmaceuticals, Llc on May 19, 2011 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 42192-338-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 42192-338-01?

    The 11-digit format is 42192033801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-242192-338-015-4-242192-0338-01