Teriparatide Injection, Solution
NDC Package 47781-652-89

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

Package Information

Teriparatide injection is teriparatide is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. This formulation utilizes a injection, solution delivery system. Marketed by Alvogen, Inc., this product is identified by NDC 47781-652 and is authorized under FDA application NDA211939.

Identification & Billing

NDC Package Code
47781-652-89
Package Description
1 SYRINGE in 1 CARTON / 2.24 mL in 1 SYRINGE
Product Code
47781-652
11-Digit Billing Format
47781065289
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Teriparatide
Non-Proprietary Name
Teriparatide
Substance Name
Teriparatide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
TERIPARATIDE 250 ug/mL
Pharmacologic Class
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
Alvogen, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211939
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-14-2019
Listing Expiration
12-31-2026
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 47781-652-89 identifies a specific commercial package of 1 syringe in 1 carton / 2.24 ml in 1 syringe of Teriparatide, a human prescription drug labeled by Alvogen, Inc.. This injection, solution is formulated for subcutaneous 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 Alvogen, Inc. on November 14, 2019. 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 Alvogen, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781065289. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
47781-652-89
11-Digit CMS (5-4-2)
47781-0652-89

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