Alendronate Sodium Solution
NDC Package 0054-0282-59

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Alendronate Sodium solution is alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. This formulation utilizes a solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0282 and is authorized under FDA application ANDA090520.

Identification & Billing

NDC Package Code
0054-0282-59
Package Description
4 BOTTLE, UNIT-DOSE in 1 CARTON / 75 mL in 1 BOTTLE, UNIT-DOSE
Product Code
0054-0282
11-Digit Billing Format
00054028259
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

Clinical Specifications

Proprietary Name
Alendronate Sodium
Non-Proprietary Name
Alendronate Sodium
Substance Name
Alendronate Sodium
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALENDRONATE SODIUM 70 mg/75mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090520
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-30-2020
Listing Expiration
12-31-2027
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 0054-0282-59 identifies a specific commercial 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.. This solution is formulated for oral use and contains alendronate sodium 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 Hikma Pharmaceuticals Usa Inc. on October 30, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054028259. 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 (4-4-2)
0054-0282-59
11-Digit CMS (5-4-2)
00054-0282-59

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