NDC Package 0054-0282-59 Alendronate Sodium

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0054-0282-59
Package Description:
4 BOTTLE, UNIT-DOSE in 1 CARTON / 75 mL in 1 BOTTLE, UNIT-DOSE
Product Code:
Proprietary Name:
Alendronate Sodium
Non-Proprietary Name:
Alendronate Sodium
Substance Name:
Alendronate Sodium
Usage Information:
Alendronate 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. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.
11-Digit NDC Billing Format:
00054028259
NDC to RxNorm Crosswalk:
  • RxCUI: 904447 - alendronate sodium 70 MG in 75 mL Oral Solution
  • RxCUI: 904447 - alendronic acid 0.933 MG/ML Oral Solution
  • RxCUI: 904447 - alendronic acid 70 MG (as alendronate sodium 91.35 mg) per 75 ML Oral Solution
  • RxCUI: 904447 - alendronic acid 70 MG per 75 ML Oral Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA090520
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-30-2020
    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 0054-0282-59?

    The NDC Packaged Code 0054-0282-59 is assigned to a package of 4 bottle, unit-dose in 1 carton / 75 ml in 1 bottle, unit-dose of Alendronate Sodium, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 0054-0282 included in the NDC Directory?

    Yes, Alendronate Sodium with product code 0054-0282 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on October 30, 2020 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 0054-0282-59?

    The 11-digit format is 00054028259. 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 4-4-2 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
    4-4-20054-0282-595-4-200054-0282-59