Teriparatide Powder
NDC Package 41524-0010-1

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.

Teriparatide powders is teriparatide is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. This formulation utilizes a powder delivery system. Marketed by Ambiopharm, Inc., this product is identified by NDC 41524-0010.

Identification & Billing

NDC Package Code
41524-0010-1
Package Description
1 g in 1 CAN
Product Code
41524-0010
11-Digit Billing Format
41524001001

Clinical Specifications

Proprietary Name
Teriparatide
Non-Proprietary Name
Teriparatide
Substance Name
Teriparatide
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)
TERIPARATIDE 1 g/g
Usage Information
Teriparatide is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone mass and strength. This effect helps to decrease the risk of getting a fracture. This medication is not recommended for use in children or young adults whose bones are still growing.

Regulatory & Marketing

Labeler Name
Ambiopharm, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-12-2017
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 41524-0010-1 identifies a specific commercial package of 1 g in 1 can of Teriparatide (UNFINISHED drug), a bulk ingredient labeled by Ambiopharm, Inc.. This powder is formulated for use and contains teriparatide 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 Ambiopharm, Inc. on December 12, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Teriparatide is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone mass and strength. This effect helps to decrease the risk of getting a fracture. This medication is not recommended for use in children or young adults whose bones are still growing.

How is this Ambiopharm, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41524001001. 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)
41524-0010-1
11-Digit CMS (5-4-2)
41524-0010-01

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