Abaloparatide Powder
NDC Package 68067-0399-1

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 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.

Abaloparatide powders is abaloparatide is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). This formulation utilizes a powder delivery system. Marketed by Polypeptide Sa, this product is identified by NDC 68067-0399.

Identification & Billing

NDC Package Code
68067-0399-1
Package Description
100 g in 1 BOTTLE, PLASTIC
Product Code
68067-0399
11-Digit Billing Format
68067039901

Clinical Specifications

Proprietary Name
Abaloparatide
Non-Proprietary Name
Abaloparatide
Substance Name
Abaloparatide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ABALOPARATIDE 1 g/g
Usage Information
Abaloparatide is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture. This medication should not be used for children or young adults whose bones are still growing.

Regulatory & Marketing

Labeler Name
Polypeptide Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-01-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 68067-0399-1 identifies a specific commercial package of 100 g in 1 bottle, plastic of Abaloparatide (UNFINISHED drug), a bulk ingredient labeled by Polypeptide Sa. This powder is formulated for use and contains abaloparatide 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 Polypeptide Sa on April 01, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Abaloparatide is used to treat bone loss (osteoporosis) for women after menopause who are at high risk of having broken bones (fractures). It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone density and strength. This effect helps to decrease the risk of having a fracture. This medication should not be used for children or young adults whose bones are still growing.

How is this Polypeptide Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68067039901. 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 (5-4-1)
68067-0399-1
11-Digit CMS (5-4-2)
68067-0399-01

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