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  5. NDC Package Code: 80426-042-01 Risedronate Sodium

NDC Package 80426-042-01 Risedronate Sodium

Tablet, Film Coated - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
80426-042-01
Package Description:
75000 TABLET, FILM COATED in 1 CONTAINER
Product Code:
80426-042
Non-Proprietary Name:
Risedronate Sodium
Substance Name:
Risedronate Sodium Monohydrate
Usage Information:
Risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Risedronate belongs to a class of medications called bisphosphonates.
11-Digit NDC Billing Format:
80426004201
Product Type:
Drug For Further Processing
Labeler Name:
Pel Healthcare Llc
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s):
  • RISEDRONATE SODIUM MONOHYDRATE 150 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    12-12-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 80426-042-01?

    The NDC Packaged Code 80426-042-01 is assigned to an UNFINISHED drug package of 75000 tablet, film coated in 1 container of Risedronate Sodium, drug for further processing labeled by Pel Healthcare Llc. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 80426-042 included in the NDC Directory?

    Yes, Risedronate Sodium is an UNFINISHED PRODUCT with code 80426-042 that is active and included in the NDC Directory. The product was first marketed by Pel Healthcare Llc on December 12, 2016 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 11-digit format for NDC 80426-042-01?

    The 11-digit format is 80426004201. 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
    5-3-280426-042-015-4-280426-0042-01